Exercise Counseling Via Mobile Chat for Older Cancer Survivors

NCT07004829 | Not Yet Recruiting

• 1 other identifier: 22233291
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the study is to determine the efficacy of a 12-week mobile chat-based exercise counselling intervention (ChatEx) for increasing exercise behaviour (operationalized as self-reported aerobic MVPA) at 3-month (primary analysis, post-intervention) and 6-month (3-month post-intervention) among older cancer survivors. This will be a randomized controlled, assessor-blind trial conforming to the CONSORT guidelines. A total of 196 cancer survivors aged over 60 who have completed curative treatment and screened as having an ECOG performance status of 0 or 1 will be recruited and randomized into intervention and control groups. It is expected that upon intervention completion, the intervention group will exhibit increased and sustained exercise behaviors compared to the control group. Study instruments will be Physical Activity Scale for the Elderly, 6-minute walk test, grip strength, Edmonton Frail Scale, European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire, M-PAC constructs, and a background questionnaire. The intervention comprises of 12 weeks of messages aimed at promoting physical activity structured with the multi-process action control framework complemented with two face-to-face exercise instructional sessions at week 1 and week 6. The control group participants will receive a one-page written information sheet on the recommended exercise guidelines and exercise safety precautions in cancer survivors. Also, they will receive 3-4 messages via IM monthly on non-exercise-related self-management tips of cancer survivorship. They can receive the ChatEx intervention upon completion of the study. Intention-to-treat analysis will be performed.

Conditions

Cancer; Survivorship; Elderly; Exercise

Keywords

Cancer survivors; Exercise counselling; Instant messaging

Outcome Measures

Primary Outcomes (1)

• Exercise behaviour

  Exercise behaviour (primary outcome) is operationalized as the self-reported time spent in aerobic MVPA per week. It will be assessed using the Physical Activity Scale for the Elderly (PASE) \[35\], a 12-item scale on three components of physical activity of older adults, including leisure-time activity (light/moderate/vigorous aerobic exercise and resistance exercise), household activity, and work-related activity. The number of hours spent on each activity/day over a 7-day period is recorded. Frequency is multiplied by duration to obtain the total time spent in aerobic MVPA. The total time spent in resistance exercise will be extracted in the same manner. An overall PASE score will be calculated to estimate total exercise time (all types of activities) by summing all components according to the item weights specified. Besides, objectively-measured time spent in MVPA will be measured by instructing participants to wear an activity sensor for 2 consecutive days at each time point.

  (a) pre-intervention at study entry (T0, baseline); (b) 3-month (T1; post-intervention); (c) 6-month (T2; 3 months post-intervention)

Secondary Outcomes (5)

• Exercise capacity

  (a) pre-intervention at study entry (T0, baseline); (b) 3-month (T1; post-intervention); (c) 6-month (T2; 3 months post-intervention)

• Grip strength

  (a) pre-intervention at study entry (T0, baseline); (b) 3-month (T1; post-intervention); (c) 6-month (T2; 3 months post-intervention)

• Health-related quality of life

  (a) pre-intervention at study entry (T0, baseline); (b) 3-month (T1; post-intervention); (c) 6-month (T2; 3 months post-intervention)

• Frailty

  (a) pre-intervention at study entry (T0, baseline); (b) 3-month (T1; post-intervention); (c) 6-month (T2; 3 months post-intervention)

• M-PAC constructs

  (a) pre-intervention at study entry (T0, baseline); (b) 3-month (T1; post-intervention); (c) 6-month (T2; 3 months post-intervention)

Study Arms (2)

ChatEx

EXPERIMENTAL

The ChatEx intervention aims to increase exercise behavior in older cancer survivors through 12 weeks of mobile messages delivered by a trained counselor, complemented by two face-to-face sessions at weeks 1 and 6 to enhance effectiveness and minimize costs. Participants will personalize their message delivery preferences (application, timing, format, language style) from a pre-existing library of text, audio, images, videos, and stickers. Messages, structured using the M-PAC framework, will provide factual information and initiate conversations, with the counselor offering real-time replies to encourage participants to meet exercise guidelines (≥150 minutes of moderate aerobic and two resistance exercise sessions per week).

Behavioral: Exercise counselling via instant messaging

Control

NO INTERVENTION

The control group participants will receive a one-page written information sheet on the recommended exercise guidelines and exercise safety precautions in cancer survivors. Also, they will receive 3-4 messages via IM monthly on non-exercise-related self-management tips of cancer survivorship. They can receive the ChatEx intervention upon completion of the study.

Interventions

Exercise counselling via instant messaging BEHAVIORAL

The 12 weeks of messages will be sent by a trained counsellor. At baseline, participants will select their desired IM application (WhatsApp/WeChat), timing of messages (morning/noon/afternoon), message format (audio/text), and language style (spoken/written). The message library, established in the HMRF-funded study, consists of messages in text and pre-recorded voice message formats, images, videos, and stickers. Each week starts with messages on factual information and ends with a question to initiate conversations to clear any queries; counsellor will provide real-time replies. The 12-week messages are structured based on the M-PAC framework.

ChatEx

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥60
• diagnosed with stage I-III non-metastatic cancer (rationale: exercise levels and interests in receiving exercise interventions are similar across cancer types in post-treatment survivors
• completed primary treatment with curative intent (rationale: post-cancer treatment period imposes less exercise barriers related to treatment schedule and side-effects, and is most desired by cancer patients to start/resume exercising
• can communicate in Cantonese or Mandarin
• have an ECOG performance status of 0 or 1
• own a smartphone and proficient in using IM

You may not qualify if:

• contraindications to unsupervised exercise (e.g., dementia, recent myocardial infarction or stroke, chronic obstructive pulmonary disease, walker or wheelchair use)
• already performing ≥150 minutes of moderate or 75 minutes of vigorous aerobic exercise and two sessions of resistance exercise per week (already meeting recommended exercise guidelines).

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Denise Shuk Ting Cheung, Ph.D.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Shuk Ting Cheung, Ph.D.

CONTACT

39176676; denisest@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent randomizer will prepare a computer-generated list of random assignments in sealed, sequentially numbered opaque envelopes. Permuted blocks of different sizes will be used to aid allocation concealment. A secure copy of the randomization list will be kept by independent personnel, serving as a central allocation centre. The outcome assessors and statistician performing data analysis will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 3 years after the manuscript on main findings is published.