Physical Activity Counselling for Young Adult Cancer Survivors

NCT ID: NCT04163042

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-04-21

Brief Summary

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Survival rates for cancer are increasing, resulting in more young adult cancer survivors living with lingering side effects. Physical activity has been shown to improve the quality and length of life in young adult cancer survivors; yet, few are active enough, and little is currently being done to promote physical activity in this population. The investigators developed a novel behaviour support intervention to promote physical activity in young adult cancer survivors. In this two-arm pilot randomized controlled trial, the investigators aim to: (1) assess trial and intervention feasibility, (2) assess trial and intervention acceptability, and (3) generate data on physical activity behaviour. Young adult cancer survivors will be randomized to receive either a 12-week behaviour support intervention delivered via videoconferencing or will be allocated to usual care.

Detailed Description

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Background: Young adults commonly experience persistent side effects following cancer treatment that impair quality of life. Physical activity (PA) holds promise as an intervention to mitigate persistent side effects and improve quality of life. Yet, few young adults are active enough to incur these benefits and efforts to promote PA following cancer treatment are lacking. Therefore, the investigators developed a novel behaviour support intervention to promote PA in young adults following cancer treatment, and have undertaken a pilot randomized controlled trial (RCT) to determine whether the intervention delivered via videoconferencing is both feasible and acceptable. Specifically, the aims of this ongoing parallel group two-arm pilot RCT are to: (1) assess trial and intervention feasibility and acceptability, and (2) generate data on PA behaviour.

Methods: Young adults who have completed cancer treatment are recruited from across Canada. Recruits are randomized to the intervention group (IG; i.e., a 12-week behaviour support intervention delivered via videoconferencing) or usual care (UC; no intervention). Drawing on the CONSORT 2010 statement and flow diagram, several feasibility outcomes pertaining to enrolment, allocation, follow-up, and analysis are tracked by study staff. Acceptability is assessed through interviews exploring IG and UC participants' experiences, thoughts, and perspectives of the trial, IG participants' views of the intervention and its mode of delivery, and PA counsellors' experiences delivering the intervention. PA is measured using accelerometers. Assessments take place at baseline (pre-randomization), post-intervention period, and at follow-up (24 weeks post-baseline).

Discussion: Feasibility and acceptability data will help determine if/what changes/modifications are needed to improve the trial protocol and/or intervention, and will inform the timeline for a definitive RCT. The PA behaviour data collected will inform sample size calculation for a future RCT that aims to test the effects of this intervention in young adults following cancer treatment.

Conditions

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Survivorship Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: Videoconferencing intervention

Participants allocated to group A will receive a behavioural support intervention via real-time videoconferencing.

Group Type EXPERIMENTAL

12-week videoconferencing behavioural support intervention to promote physical activity behaviour

Intervention Type BEHAVIORAL

Participants in Group A will receive six real-time, 1-on-1 60-minute sessions led by a physical activity counsellor over a 12-week period. Sessions will be delivered via videoconferencing and will aim to provide young adult cancer survivors with support as well as the knowledge, skills, and confidence to identify and overcome challenges to engaging in physical activity in order to increase physical activity behaviour and enhance patient-reported outcomes.

Group B: Usual care

Participants allocated to group B will receive usual care and will be advised to continue with their regular activities of daily living.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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12-week videoconferencing behavioural support intervention to promote physical activity behaviour

Participants in Group A will receive six real-time, 1-on-1 60-minute sessions led by a physical activity counsellor over a 12-week period. Sessions will be delivered via videoconferencing and will aim to provide young adult cancer survivors with support as well as the knowledge, skills, and confidence to identify and overcome challenges to engaging in physical activity in order to increase physical activity behaviour and enhance patient-reported outcomes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Currently between the ages of 18-39 years;
* Received a first diagnosis of invasive cancer between the ages of 18-39 years;
* Completed primary treatment for cancer \<5 years;
* Able to provide informed consent in English or French;
* Have approval of a healthcare provider to participate in the trial;
* Have access to videoconferencing technology (e.g., Skype, Google Hangouts, FaceTime).

Exclusion Criteria

* Have evidence of current cancer (recurrent or secondary cancer or relapse);
* Currently meeting the Canadian Society for Exercise Physiology aerobic physical activity guidelines for cancer survivors in the month prior to enrolment (i.e., 150 minutes/week of moderate-to-vigorous intensity aerobic physical activity);
* Are non-ambulatory.
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ottawa

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Brunet

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Ottawa

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

Reference Type BACKGROUND
PMID: 1593914 (View on PubMed)

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

Reference Type BACKGROUND
PMID: 3397865 (View on PubMed)

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

Reference Type BACKGROUND
PMID: 11556941 (View on PubMed)

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

Reference Type BACKGROUND
PMID: 16717171 (View on PubMed)

Husson O, Zebrack BJ. Psychometric Evaluation of an Adolescent and Young Adult Module of the Impact of Cancer Instrument. J Adolesc Young Adult Oncol. 2017 Mar;6(1):159-170. doi: 10.1089/jayao.2016.0038. Epub 2016 Sep 21.

Reference Type BACKGROUND
PMID: 27654343 (View on PubMed)

Marcus BH, Rakowski W, Rossi JS. Assessing motivational readiness and decision making for exercise. Health Psychol. 1992;11(4):257-61. doi: 10.1037//0278-6133.11.4.257.

Reference Type BACKGROUND
PMID: 1396494 (View on PubMed)

Brunet J, Price J, Srikanthan A, Gillison F, Standage M, Taljaard M, Beauchamp MR, Reed J, Wurz A. The physicAl aCtivity Counselling for young adult cancEr SurvivorS (ACCESS) trial: A protocol for a parallel, two-arm pilot randomized controlled trial. PLoS One. 2022 Dec 30;17(12):e0273045. doi: 10.1371/journal.pone.0273045. eCollection 2022.

Reference Type DERIVED
PMID: 36584027 (View on PubMed)

Related Links

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https://doi.org/10.1123/jsep.28.3.231

Psychological Need Satisfaction in Exercise Scale

https://doi.org/10.3389/fpsyg.2018.01940

Behavioural Regulation in Exercise Questionnaire-3

Other Identifiers

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20190643-01H

Identifier Type: -

Identifier Source: org_study_id

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