Exercise Counseling Via Mobile Chat for Older Cancer Survivors (ChatEx)

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Survivorship; Elderly; Cancer; Exercise

Treatments: Behavioral: Exercise counselling via instant messaging

Study type: Interventional

Funder types: Other

Identifiers

NCT07004829

22233291

Details and patient eligibility

About

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.

Full description

Older adults account for more than half of cancer diagnoses. With advances in detection and treatment, older adults constitute the fastest-growing segment in the cancer population. A history of cancer has been found to increase the odds of and accelerate functional decline, suggesting that cancer and/or its treatment alters aging trajectories. Therapeutic interventions are therefore needed to mitigate the consequences of cancer and aging. Robust evidence indicates that exercise attenuates the major hallmarks of aging. Meanwhile, exercise is recommended by multiple best practice guidelines to alleviate the adverse sequelae of cancer. Well-documented benefits include improvements in physical functioning and quality of life (QoL), reduction of cancer-related symptoms (e.g., fatigue, insomnia, depression), and decreasing risk of recurrence, secondary cancers, and mortality.

Exercise counseling, which involves advice and discussions to promote exercise, is a less intensive and more scalable approach than supervised exercise sessions. Instant messaging (IM) offers a promising platform for delivering exercise counseling due to its accessibility, customizability, and widespread use. This study utilizes the Multi-Process Action Control (M-PAC) framework, which emphasizes reflective, regulatory, and reflexive processes to overcome barriers to exercise adherence. The study hypothesizes that ChatEx, an IM-based exercise counseling intervention grounded in the M-PAC framework, will be effective in increasing and maintaining exercise behavior among older cancer survivors.

This study aims to evaluate the efficacy of a 12-week mobile chat-based exercise counseling intervention (ChatEx) for increasing exercise behavior in older cancer survivors. The primary objective is to determine if ChatEx can increase exercise behavior at both 3-month (post-intervention) and 6-month (3-month post-intervention) time points. Secondary aims include examining the intervention's impact on other exercise parameters, exercise capacity, grip strength, frailty, and quality of life, as well as exploring the mediating roles of Multi-Process Action Control (M-PAC) constructs and participant engagement in changing exercise behavior.

Enrollment: 196 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. aged ≥60
2. 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
3. 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
4. can communicate in Cantonese or Mandarin
5. have an ECOG performance status of 0 or 1
6. own a smartphone and proficient in using IM

Exclusion criteria

1. contraindications to unsupervised exercise (e.g., dementia, recent myocardial infarction or stroke, chronic obstructive pulmonary disease, walker or wheelchair use)
2. 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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196 participants in 2 patient groups

ChatEx

Experimental group

Description:

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).

Treatment:

Behavioral: Exercise counselling via instant messaging

Control

No Intervention group

Description:

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.