Physical Activity Counselling for Young Adult Cancer Survivors

NCT04163042 | Completed

• 1 other identifier: 20190643-01H
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Survivorship; Cancer

Keywords

Physical activity; Behavioural support; Oncology; Telehealth; Self-determination theory; Behaviour change techniques; Young adult cancer survivors

Outcome Measures

Primary Outcomes (6)

• Recruitment rates

  The number of eligible participants who enrol in the trial out of the number who are referred

  Duration of study (24 months)

• Adherence rates

  The number of intervention sessions attended out of the total recommended as part of the intervention

  Duration of study (24 months)

• Acceptability of the trial and intervention

  Participants will be asked to share their experiences, thoughts, and perspectives of the trial, the physical activity counsellor and the intervention by responding to open and close-ended questions during a semi-structured interview. Responses to close-ended questions will range from 1 ('poor' or 'not satisfied at all') to 10 ('excellent' or 'extremely satisfied').

  At week 12

• Retention rates

  The number of participants completing all three scheduled assessments.

  Duration of study (24 months)

• Data completeness: Quantitative measures

  The percentage of missing data on quantitative measures.

  Duration of study (24 months)

• Data completeness: Qualitative interviews

  The number of participants completing the acceptability interview following the intervention.

  Duration of study (24 months)

Secondary Outcomes (9)

• Physical activity behaviour: 7-day accelerometer wear (objective physical activity behaviour)

  Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)

• Health-related quality of life: RAND 36-Item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)

  Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)

• Positive and negative affect: Positive and Negative Affect Schedule (PANAS-SF; Watson, Clark & Tellegen, 1998)

  Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)

• Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9; Kroenke, Spitzer & Williams, 2001)

  Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)

• Anxiety symptoms: 7-item Patient Health Questionnaire Generalized Anxiety Disorder Scale (GAD-7; Kroenke, Spitzer & Williams, 2006)

  Baseline (week 0), post-intervention (week 12), post-intervention follow-up (week 24)

Other Outcomes (1)

• Socio-Demographic and Medical Information Questionnaire

  Baseline (week 0)

Study Arms (2)

Group A: Videoconferencing intervention

EXPERIMENTAL

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

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

Group B: Usual care

NO INTERVENTION

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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

Location

Related Publications (8)

• 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.

  PMID: 1593914 BACKGROUND

• 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.

  PMID: 3397865 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 27654343 BACKGROUND

• 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.

  PMID: 1396494 BACKGROUND

• Brunet J, Price J, Gillison F, Standage M, Taljaard M, Beauchamp MR, Reed J, Srikanthan A. Feasibility and acceptability of a parallel, two-arm randomized controlled trial to evaluate an online physical activity behavior counseling intervention for young adults diagnosed with cancer: a mixed-methods pilot study. Pilot Feasibility Stud. 2025 Nov 4;11(1):131. doi: 10.1186/s40814-025-01701-w.

  PMID: 41189005 DERIVED

• 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.

  PMID: 36584027 DERIVED

Related Links

• Psychological Need Satisfaction in Exercise Scale
• Behavioural Regulation in Exercise Questionnaire-3

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 14, 2019
• Study Start: March 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: April 21, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

CA (1)