Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000039987
Ethics application status
Approved
Date submitted
15/11/2019
Date registered
21/01/2020
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity intervention programme for cancer survivors to improve physical activity level
Scientific title
Effectiveness of Home-based Physical Activity for Survivors (HoPS) programme in enhancing physical activity among National Cancer Society Malaysia's Volunteers.
Secondary ID [1] 299801 0
None
Universal Trial Number (UTN)
U1111-1243-5319
Trial acronym
HoPS
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 315186 0
Colorectal cancer 315187 0
Condition category
Condition code
Cancer 313501 313501 0 0
Breast
Cancer 313842 313842 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention arm is named HoPS, an acronym of Home-based Physical Activity for Survivors.
HoPS intervention programme aims to improve physical activity level among cancer survivors, in particular breast and colorectal cancer by employing Social Cognitive Theory (SCT) in the development of the programme. It combines of psychoeducation and social media approach to behavioural intervention. Participants of the HoPS will be provided with a non-tailored printed material and gradual tapering down of face-to-face group meetings to improve knowledge and skills of physical activity. While WhatsApp is used as a structured direct remote feedback strategy to allow for supervised home-based physical activity.

1. Face-to-face group meetings
There will be 2 meet up sessions for all participants in the HoPS group. The sessions provide a standardized lectures deliver by the researcher using power point slides. The first session of lecture (1-hour duration) will cover the areas of a brief introduction of HoPS programme, physical activity knowledge and goal setting. The second session of lecture (15-minutes duration) will cover for barriers to physical activity and following that a sharing session (15-minutes duration) by a role model (a cancer survivor) to share her experience in engaging in physical activity. In each of the sessions, after the lectures, an exercise session will be conducted by a certified exercise instructor with at least 3 years experienced in coaching for exercise. The duration of this exercise session will be 2 hours and the focus is train the participants on how to perform a proper and correct exercise for cancer survivors. This will involved aerobic exercises and resistance exercises as described below:
-First session
Aerobic exercise: Upper (eg. push up, wide push up, tricep dip and bicep curl) and lower (eg.squat, squat cross jump, front lunges, reverse lunges and side lunges) body workout.
Resistance exercise: heel step down, leg adduction, plank and short arc squats
-Second session
Aerobic exercise: Core/Abs workout (eg. plank, rotation plank, bicycle crunch, hang and flutters kick) and total body workout (eg. inchworm, body builder, mountain cross and mountain climbers).
Resistance exercise: heel step down, leg adduction, plank and short arc squats

2. Booklet
A non-tailored printed materials will also be given to HoPS participants which served as a handout from the lectures given in face-to-face group meetings and inclusive of their personal physical activity dairy. The booklet is designed specifically for this study and it is customized to Malay language. It is a standardized booklet and participants will be taught on how to set goals, make schedule for their physical activity and to track their physical activity.

3. WhatsApp messages
A structured direct remote contact feedback strategy via WhatsApp is used to allow supervised feedback to the HoPS participants. Every week (from week 2 to week 8) participants will be asked to complete short IPAQ (International Physical Activity Questionnaire) to assess their physical activity level. The results will be analysed using excel for analysis of daily pattern activity and weekly moderate intensity of physical activity.Participants will receive WhatsApp messages each week as described below:
-Week 2-4 (Frequency 1): Visual graphic presentation of individual progress of physical activity will be sent through WhatsApp.
-Week 5 (Frequency 1): Visual graphic presentation of individual progress of physical activity will be sent through WhatsApp and subsequently a standardized messages of physical activity knowledge will follow.
-Week 6 (Frequency 1): Visual graphic presentation of individual progress of physical activity will be sent through WhatsApp and subsequently a standardized messages of physical activity barriers will follow.
-Week 7 (Frequency 1): Visual graphic presentation of individual progress of physical activity will be sent through WhatsApp and subsequently a standardized messages of physical activity goal setting will follow.
-Week 8 (Frequency 1): Visual graphic presentation of individual progress of physical activity will be sent through WhatsApp and subsequently a standardized messages on motivation from the exercise model's advice will follow.

The HoPS intervention programme will be a two-month intervention programme, which is planned to be delivered in two phases; a training phase (four weeks) and a booster phase (four weeks). In the training phase, the face-to-face group meetings will be held on week 1 and 3, while the structured remote feedback strategy will be delivered weekly during the training phase. In the booster phase from week 5 to 8, weekly standardized WhatsApp messages will be sent to the participants which cover the lectures given during the face-to-face group meetings. Similar to training phase, structured remote feedback strategy continues until week 8.

For adherence to HoPS intervention programme, participants will be assessed from the attendance to the two sessions of the face-to-face group discussion and for the intervention of direct remote contact for feedback strategy, the adherence is according to reply or filling up the IPAQ online.
Intervention code [1] 316067 0
Rehabilitation
Intervention code [2] 316068 0
Lifestyle
Intervention code [3] 316069 0
Behaviour
Comparator / control treatment
The HoPS intervention programme will be given to the control group once the final data collection has been completed (wait-list control). While on the wait-list no intervention is given.
Control group
Active

Outcomes
Primary outcome [1] 321962 0
Total MET-minutes/week using validated IPAQ
Timepoint [1] 321962 0
Baseline, at 8-week (immediately after intervention) and at 16-week post intervention
Secondary outcome [1] 376805 0
Quality of life assessed using the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ 30) version 3
Timepoint [1] 376805 0
Baseline, at 8-week (immediately post intervention) and at 16-week post intervention
Secondary outcome [2] 376806 0
Self-efficacy is measured using a four-item scale developed for patients with chronic disease. The instrument has been validated previously (Rogers, Humphries, Davis, & Gutin, 1998).
Timepoint [2] 376806 0
Baseline, at 8-week (immediately post intervention) and at 16-week post intervention
Secondary outcome [3] 376808 0
Behavioural capability is measured using 6-items assessing specific components of physical activity knowledge and skill that is adopted from study Move More for life (Rogers, Humphries, Davis, & Gutin, 1998). However, it was not validated
Timepoint [3] 376808 0
Baseline, at 8-week (immediately post intervention) and at 16-week post intervention
Secondary outcome [4] 376809 0
Outcome expectations was measured using five general items from the validated exercise pro subscale. The instrument has been validated previously.
Timepoint [4] 376809 0
Baseline, at 8-week (immediately post intervention) and at 16-week post intervention.
Secondary outcome [5] 376811 0
Reinforcement is measured using four questions and previously tested for reliability and validity (Marcus, Rossi, Selby, Niaura, & Abrams, 1992).
Timepoint [5] 376811 0
Baseline, at 8-week (immediately post intervention) and at 16-week post intervention
Secondary outcome [6] 376812 0
Social support is measured using the Social Support and Exercise (Modified Sallis). The instrument has been validated previously.
Timepoint [6] 376812 0
Baseline, at 8-week (immediately post intervention) and at 16-week post intervention

Eligibility
Key inclusion criteria
i.Malaysian citizen breast or colorectal cancer patient between the age of 18 years old and 65 years old who are registered with National Cancer Society Malaysia (NCSM) and are actively involved with 3 branches of NCSM at Kuala Lumpur, Negeri Sembilan and Melaka
ii. Stage I to III (or IIIA for breast cancer) who are not currently receiving (and do not plan to receive during the duration of study enrollment) chemotherapy or radiation therapy
iii.More than 8 weeks post-surgical procedure
iv. Post-treatment three months
v.Obtained medical clearance from physician
vi. Grade 0 or 1 for ECOG Performance Status
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Participating, on average, 30 to 60 min per day (greater than or equal to 150 min per week) of moderate intensity for at least 5 days per week or 20 to 30 min per day (greater than or equal to 75min per week) of vigorous intensity for at least 5 days per week or an equivalent combination of the two
ii. Medical or psychological condition that would interfere with the ability to fully participate during the study enrollment (e.g., psychosis, schizophrenia, etc.)
iii. Recurrent disease,
iv. Elective surgery planned during the duration of the intervention that would interfere with intervention participation (e.g., breast reconstructive surgery), and
v. Planned travel that interferes with the scheduled study sessions (i.e., no travel in the first 4 weeks and no travel in the last week of the intervention).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Third-party assignment will be used where each eligible participant will be number coded by the researcher whereby only the researcher will have access to the cancer survivor names and the codes to ensure safe keeping and confidentiality of all records. Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site using the list of these codes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation is based on detecting mean differences of total physical activity MET- min/week from previous study within intervention group at 12 weeks (immediately after intervention) using the standard formula for individual randomisation trial. It is calculated based on 95% level of significance and 80% power. The dropout rate is assumed at about 20% after randomization. After accounting for non-participation among eligible participants of 10%, the total number of participants in this study for both HoPS intervention group and wait-list group is 106.

Statistical Package of Social Sciences System (SPSS) version 25 will be used to analyse the data for this study. In assessing for the effectiveness of the HoPS intervention programme, the data will be analysed using intention-to-treat (ITT) analysis.
For inferential statistic, t-test / Mann Whitney U test and Chi square test/Fisher exact test will be conducted for continuous and categorical measurements, respectively. These tests will be formulated at baseline to look for homogeneity as well as at post-intervention to determine the differences between the intervention group and the wait-list group. Generalised Estimating Equation (GEE) analysis will be used to evaluate the effectiveness of the intervention, adjusted for baseline covariates on both continuous and categorical outcomes. This study will be using a significance level of 0.05 with a confidence interval of 95% for means estimation to reject null hypothesis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2020
Actual
Date of last participant enrolment
Anticipated
3/01/2021
Actual
Date of last data collection
Anticipated
25/04/2021
Actual
Sample size
Target
106
Accrual to date
Final
Recruitment outside Australia
Country [1] 22108 0
Malaysia
State/province [1] 22108 0
Kuala Lumpur
Country [2] 22109 0
Malaysia
State/province [2] 22109 0
Negeri Sembilan
Country [3] 22110 0
Malaysia
State/province [3] 22110 0
Melaka

Funding & Sponsors
Funding source category [1] 304276 0
Other Collaborative groups
Name [1] 304276 0
National Cancer Society Malaysia
Country [1] 304276 0
Malaysia
Primary sponsor type
University
Name
UNIVERSITI PUTRA MALAYSIA
Address
Community Health Department,
Faculty of Medicine and Health Sciences,
Universiti Putra Malaysia
43400, Serdang,
Selangor,
Country
Malaysia
Secondary sponsor category [1] 304520 0
None
Name [1] 304520 0
Address [1] 304520 0
Country [1] 304520 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304718 0
Ethics Committee for Research Involving Human Subjects/ Jawatankuasa Etika Universiti untuk Penyelidikan melibatkan Manusia(JKEUPM)
Ethics committee address [1] 304718 0
Ethics committee country [1] 304718 0
Malaysia
Date submitted for ethics approval [1] 304718 0
02/08/2019
Approval date [1] 304718 0
11/10/2019
Ethics approval number [1] 304718 0
JKEUPM-2019-323

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97986 0
A/Prof Nor Afiah Mohd Zulkefli
Address 97986 0
Community Health Department,
Faculty of Medicine and Health Sciences,
Universiti Putra Malaysia,
Serdang, 43400 Seri Kembangan,
Selangor
Country 97986 0
Malaysia
Phone 97986 0
+60125289553
Fax 97986 0
Email 97986 0
[email protected]
Contact person for public queries
Name 97987 0
Mardiana Omar
Address 97987 0
Community Health Department,
Faculty of Medicine and Health Sciences,
Universiti Putra Malaysia,
Serdang, 43400 Seri Kembangan,
Selangor
Country 97987 0
Malaysia
Phone 97987 0
+60162200662
Fax 97987 0
Email 97987 0
[email protected]
Contact person for scientific queries
Name 97988 0
Mardiana Omar
Address 97988 0
Community Health Department,
Faculty of Medicine and Health Sciences,
Universiti Putra Malaysia,
Serdang, 43400 Seri Kembangan,
Selangor
Country 97988 0
Malaysia
Phone 97988 0
+60162200662
Fax 97988 0
Email 97988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data (after de-identification) underlying published results only.
When will data be available (start and end dates)?
Immediately following publication and ending 5 years following main results publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5689Informed consent form    378732-(Uploaded-14-11-2019-18-19-57)-Study-related document.pdf
5690Ethical approval    378732-(Uploaded-14-11-2019-18-20-13)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of an independent physical activity programme in improving physical activity amongst breast and colorectal cancer survivors: Study protocol for a randomized controlled trial.2021
N.B. These documents automatically identified may not have been verified by the study sponsor.