We will complete a prospective, parallel, assessor-blinded, pragmatic randomized controlled trial comparing the efficacy and cost-effectiveness of 8 weeks of group exercise–based cancer telerehabilitation to usual care (see Figure 1 for the study flowchart). Participants will be assessed at weeks 0 (baseline), 9 (post intervention), and 26 (follow-up) (Multimedia Appendix 1). Quantitative trial outcomes will be reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) statement [28], qualitative outcomes reported with consolidated criteria for reporting qualitative research [29] and health economic analysis reported with the Consolidated Health Economic Evaluation Reporting Standards [30]. The qualitative component of the study will be conducted using an interpretivist paradigm, which recognizes that multiple realities exist and this is affected by context [31].

Eligible participants who have completed baseline measurements will be randomly allocated to the telerehabilitation group or usual care control group using a concealed method in accordance with a web-based computer-generated randomization program using permuted blocks of 4, 6, and 8 participants. Allocations will be prepared prior to trial commencement by an independent researcher with no role in participant recruitment, trial administration of intervention delivery, or assessments. The trial coordinator will allocate participants after baseline assessment by contacting the independent researcher via email for random group allocation.

The trial will be conducted in a large public health network in Melbourne, Victoria, Australia, which services approximately 3000 cancer survivors annually. Participants will be recruited from cancer services at 3 metropolitan sites within this single health network.

The TeleCaRe trial has been approved by the Eastern Health and La Trobe University Human Research Ethics Committees (E21-012-74698) and is funded by the Victorian Cancer Agency.

Eligible participants will be identified by any member of the cancer services clinical team at the health network (eg, oncologists, nursing staff, and physiotherapists). Potential participants will be advised about the trial by clinic staff verbally or through flyers. If a patient consents, he/she will be contacted by a member of the research team who will provide details of the trial and arrange an outpatient appointment at home or at the clinical site to provide an opportunity for questions to be clarified and to provide written informed consent.

Participants will be eligible if they are aged 18 years and over, have a cancer diagnosis and are receiving cancer treatment (palliative or curative intent) or are within 12 months of completing adjuvant therapy (except for long term oral hormonal therapies), are functioning independently in the community (Australian Karnofsky Performance Status [AKPS] score≥60), are at a low risk of falls (Falls Risk for Older People in the Community score<4), are able to speak conversational English so participants can engage effectively in videoconferencing, have access to and be willing to use the internet, and be able to give written informed consent.

Participants will be excluded if they are medically unfit to participate in exercise as determined by a physiotherapist or medical practitioner on the basis of published recommendations [32], are residing in residential care or are an inpatient, or have cognitive impairment precluding the ability to provide written informed consent as assessed by their treating clinician.

All participants will receive their usual medical care, which may include adjuvant, neoadjuvant, or palliative treatment, specialist, nursing and other health outpatient appointments (eg, to see a physiotherapist) and visits to their general practitioner.

As part of the trial, all participants will be provided with written educational materials relating to different aspects of cancer recovery (eg, exercise, nutrition, and fatigue) via standardized print or digital material readily available from the hospital.

Usual care in the community involves very little exercise support in relation to exercise. As part of the trial, usual care also includes standardized verbal and written advice to complete physical activity in line with current recommendations (aim for 3 times weekly exercise for 30 minutes, including twice weekly strength training) [4]. All participants will also have the opportunity to discuss their ongoing rehabilitation needs at the end of the 8-week intervention period. They will be provided written information for referral to appropriate local services for ongoing support if required in line with usual practice at the health service.

In addition to usual care, participants randomized to the experimental group (telerehabilitation) will receive a 60-minute group exercise delivered by a physiotherapist via videoconferencing (Zoom) twice-weekly for 8 weeks. Exercise will comprise cardiovascular and resistance training guided by published recommendations [4]. Exercise sessions will be individually tailored and include the use of free weights, resistance bands, body weight, and functional activities. Supervised aerobics (eg, marching in place and side-stepping) will comprise the cardiovascular component. Participants will be provided with an exercise band, and the exercise program will be supplemented by participants’ own exercise equipment or household items. The therapist will choose an exercise variation (eg, bicep curl using weights or with exercise band) based on the equipment available to the participant. Various upper- and lower-body stretches and balance exercises will be incorporated as required. Exercise intensity will be monitored during the exercise class using a Fitbit device (Fitbit Inspire) and modified Borg scale. The Fitbit will also be used for participants to self-monitor their physical activity levels throughout the 8-week intervention. A home exercise program will supplement exercise-based telerehabilitation sessions and be delivered via a web application (Physitrack). The home exercise program will encourage one additional 30-minute aerobic exercise session per week (eg, walking) during the intervention period and will be updated at the end of the rehabilitation program to encourage participants to conduct twice-weekly strength training and 3 times weekly aerobic training after the 8-week intervention period. Participants will also be provided education materials relating to different aspects of cancer recovery (eg, nutrition, emotions, and fatigue) via a web-based information portal (iLearn, Totara Learning Solutions, Wellington, New Zealand) (Table 1).

Physiotherapists conducting assessments and providing the exercise intervention will be trained in exercise rehabilitation for cancer survivors. They will participate in a 1-day web-based training session about cancer care and complete a self-directed web-based module about cancer-related fatigue management. They will also participate in 2 interactive 2-hour in-person workshops about exercise prescription for cancer survivors. They will also have access to a website [33] that provides education for clinicians providing exercise-based cancer rehabilitation. Physiotherapists will receive monthly clinical supervision in line with health service policy and regular mentoring with senior research staff. The fidelity of the intervention will be monitored by recording the content of exercise sessions using logbooks, including the number and duration of completed sessions. Participants in both groups will also be asked whether they received any exercise-based intervention outside of the trial at the 9-week assessment and 4-month follow-up.

Participants will complete an assessment of health-related quality of life at weeks 0, 9, and 26. Immediately post intervention (week 9) is the primary end point. Walking capacity and self-efficacy will also be assessed at weeks 0 and 9. Physical activity and health service usage utilization will be assessed at weeks 0 and 26. A clinician blind to group allocation will complete the assessments. Primary and secondary outcomes are outlined in Table 2.

Adverse events as defined by the World Health Organization [35] will be recorded from medical records, direct observation during classes, and by participant self-report to document the safety of the intervention. The event may or may not be related to the intervention but occurs while the person is participating in the intervention phase of the trial. Adverse events will be categorized as either minor or serious and as related or unrelated and expected or unexpected events. A minor adverse event is defined as an incident that occurs while a person is participating in the intervention that results in no injury or minor injury (eg, exacerbation of pre-existing musculoskeletal pain) that requires no or minor medical intervention. A serious adverse event is defined as an incident that occurs while a person is participating in the intervention that results in death, serious injury, or hospitalization (eg, injurious fall resulting in fracture). Serious adverse events will also be recorded for the usual care group. In addition, adverse events will be reported and graded using the Common Terminology Criteria for Adverse Events Version 4 [36]. The consequences of a serious adverse event in the control group (eg, hospitalization and emergency department admission) will be captured by our health service utilization questionnaire and medical record audit. Reasons for nonparticipation in an exercise session or noncompletion of the program will be recorded (eg, pain, fatigue, and unwell).

Semistructured interviews will be completed on 2 occasions (immediately after the intervention at week 9 and at week 26) with experimental group participants to explore in detail the experience of people participating in exercise-based cancer telerehabilitation and of behavior change. A purposive sample of participants in the telerehabilitation group will be asked questions relating to satisfaction, barriers, and facilitators to accessing cancer telerehabilitation and perceptions about sustaining physical activity on program completion. The same group will be interviewed at both time points. We will conduct interviews until we reach data saturation; that is, until no new ideas emerge from the data [37]. It is anticipated that this will be achieved by interviewing approximately 20 participants based on our previous qualitative studies of cancer rehabilitation [7,11]. Interviews of approximately 45-minute duration will be conducted in person, via the telephone, or through videoconference, if preferred, by a member of the research team. A different interview schedule at each time point (Multimedia Appendix 4) will be given to participants prior to the interview to allow them to prepare.

Other routinely collected data will be used to describe the sample, including age, gender, cancer type, cancer stage, treatment regimens, comorbidities, baseline functional performance status (AKPS), and baseline BMI.

It is estimated that 104 participants will be required to accomplish a power of 0.80 and a 2-tailed α level of .05 to detect a between-group difference of a 10-point change in the EORTC QLQ-C30 score [38] (the minimally important difference established for cancer survivors) assuming an SD of 18 points [39]. Based on our previous trial of cancer rehabilitation [39], we expect a dropout of 10%; therefore, 116 participants will be randomized.

It is hypothesized that patients receiving cancer telerehabilitation will demonstrate improvements in health-related outcomes when compared to usual care without rehabilitation. It is also hypothesized that a cancer telerehabilitation model will be cost-effective and demonstrate high patient satisfaction. These findings will inform future development of cancer rehabilitation programs in hospital-based settings, contributing to the global effort to integrate exercise-based rehabilitation into standard cancer care [1]. Telehealth may be a convenient and effective way to increase access to exercise. However, no previous randomized controlled trials have evaluated supervised, web-based group exercise via videoconferencing in a real-world health setting [15,24]. This trial will compare a comprehensive, exercise-based cancer telerehabilitation program, delivered in a supervised group and usual care on patient and health service outcomes within a pragmatic health service setting.

There are many possible advantages of exercise-based cancer telerehabilitation. Most notable is the possibility to reach a broader population of cancer survivors. Many existing cancer rehabilitation programs are centered in metropolitan areas [3,45]; hence, there is potential to improve access for those in regional and rural areas. Telerehabilitation also may provide an extra element of convenience for a population that usually has a high number of competing medical demands [11]. However, the convenience of telerehabilitation may be countered by the inability to provide exercise interventions with hands-on instruction and the use of specific equipment. There may also be additional challenges related to supervision and exercise monitoring, which may affect the fidelity of telerehabilitation. Despite this possible concern, telerehabilitation generally meets consumer needs [46], and patients have positive views of this type of service delivery [15,16].

A strength of this study is the inclusion of health service data. Few studies on cancer rehabilitation include end points meaningful to health services such as hospital length of stay, readmissions, health service utilization, and medication use [47]. This is an issue since costs are a key driver of decision-making in health care. Telerehabilitation has been demonstrated to reduce hospital readmissions compared to usual care in people with advanced-stage cancer and has shown cost savings in other chronic disease settings [48-50]. If shown to be cost-effective, results from this trial may encourage greater implementation of telerehabilitation in cancer settings to improve access to exercise for cancer survivors.

The pragmatic nature of this study implies that a possible limitation is the requirement of participants to have access to their own technology infrastructure to support telehealth. This may bias the population to include participants who have high levels of digital health literacy and access to technology. However, 86% of Australian households have access to the internet, with 91% of them using smartphones and 66% using tablets [51]. This approach is also consistent with the likelihood that future implementation of telerehabilitation programs would be targeted toward people who own suitable devices and have internet access. This trial also does not consider other models of rehabilitation such as 1:1 care. Given that high levels of supervision are important for effectively delivering exercise for cancer survivors [4], possible effects of the telerehabilitation intervention may be diluted owing to the inability to interact 1:1 in a web-based group setting. To account for this, the staff ratio has been kept high to support technology and practical difficulties that patients may encounter.

Telerehabilitation is a rapidly growing area that may have many positive impacts among cancer survivors. This trial has the potential to inform future models of cancer rehabilitation, which can be implemented in health services to improve access to exercise for cancer survivors.