NCT03691545

Brief Summary

Participating in regular physical activity and consuming a diet high in fruits and vegetables can aid in the management of various acute and chronic side effects of cancer treatment; however, few rural-dwelling young adult cancer survivors are active enough and consume enough fruits and vegetables to accrue benefits. Telehealth interventions show promise for helping these young adults increase their motivation to participate in these behaviours by addressing barriers associated with accessing face-to-face behaviour counselling services (e.g., time commitment, travel distance). Yet, few researchers have examined the feasibility and acceptability of a telehealth intervention that provides motivational support grounded in self-determination theory for these health behaviours in rural-dwelling young adult cancer survivors. Based on previous research, the researchers reasoned that rural-dwelling young adult cancer survivors' physical activity and fruit and vegetable consumption would be more likely to increase if they participated in a telehealth intervention therefore, the researchers aim to test the feasibility, acceptability, and preliminary efficacy of the intervention. The researchers also aim to assess if changes in perceived basic psychological need satisfaction, behaviour regulation, and perceived autonomy support are associated with changes in physical activity and fruit and vegetable consumption.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

September 27, 2018

Last Update Submit

March 6, 2020

Conditions

Keywords

physical activityfruit and vegetable consumptiontelehealthyoung adult cancer survivorsrural-dwelling

Outcome Measures

Primary Outcomes (2)

  • Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S; Booth, 2000).

    Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention, with higher scores representing a better outcome.

    Baseline (week 0) and post-intervention (week 12)

  • Fruit and vegetable intake behaviour: Behavioural Risk Factor Surveillance System Fruit and Vegetable section (BRFSS-FV; Trowbridge, Wong, Byers, & Serdula, 1990)

    Change in self-reported fruit and vegetable intake (over the past 7 days) from baseline to post-intervention, with higher scores representing a better outcome.

    Baseline (week 0) and post-intervention (week 12)

Secondary Outcomes (9)

  • Basic psychological needs satisfaction for physical activity: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006)

    Baseline (week 0) and post-intervention (week 12)

  • Basic psychological need satisfaction for fruit and vegetable consumption: Psychological Need Satisfaction questionnaire (PNS; Deci, Ryan, Gagne, Leone, Usunov, & Kornazheva, 2001)

    Baseline (week 0) and post-intervention (week 12)

  • Motivational regulations for physical activity: Exercise Treatment Self-Regulation Questionnaire (TSRQ-E; Williams, Deci, & Ryan, 1998)

    Baseline (week 0) and post-intervention (week 12)

  • Motivational regulations for fruit and vegetable consumption: Dietary Self-Regulation questionnaire (DSR; Williams, Deci, & Ryan, 1998)

    Baseline (week 0) and post-intervention (week 12)

  • Perceived autonomy support: Health Care Climate Questionnaire (HCCQ; Williams, Grow, Freedman, Ryan, & Deci, 1996)

    Post-intervention (week 12)

  • +4 more secondary outcomes

Study Arms (1)

Intervention Group

EXPERIMENTAL

(1) 12 weekly interactive sessions with a health coach to help them set goals and make changes toward becoming physically active and consuming the recommended number of fruits and vegetables.

Behavioral: interactive sessions

Interventions

This arm will receive personalized health coaching (behaviour change counseling)

Intervention Group

Eligibility Criteria

Age20 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Are between the ages of 20-39 years
  • Live in a rural area (i.e., areas with \<35,000 inhabitants)
  • Have completed primary treatment for non-metastatic cancer
  • Are not currently meeting the American Cancer Society guidelines for physical activity and fruit and vegetable consumption
  • Have access to the Internet and to audio-visual devices
  • Are willing to provide informed consent to participate in this study and willing to follow study protocol
  • Able to read and understand English
  • Are ambulatory

You may not qualify if:

  • Have a serious condition that precludes safe participation in physical activity
  • Have symptomatic heart or vascular diseases (angina, peripheral vascular disease, congestive heart failure)
  • Have severe hypertension
  • Have had a recent stroke
  • Have a chronic obstructive pulmonary disease
  • Have severe insulin-dependent diabetes mellitus
  • Have renal disease
  • Have liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

Location

Related Publications (7)

  • Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.

    PMID: 10925833BACKGROUND
  • Deci, E. L., Ryan, R.M., Gagne, M., Leone, D.R., Usunov, J., & Kornazheva, B.P. (2001). Need satisfaction, motivation, and well-being in the work organizations of a former eastern bloc country: A cross-sectional study of self-determination. Journal of Personality and Social Psychology, 27(8), 930-942.

    BACKGROUND
  • Trowbridge FL, Wong FL, Byers TE, Serdula MK. Methodological issues in nutrition surveillance: the CDC experience. J Nutr. 1990 Nov;120 Suppl 11:1512-8. doi: 10.1093/jn/120.suppl_11.1512.

    PMID: 2173743BACKGROUND
  • Williams, G. C., Deci, E. L., & Ryan, R. M. (1998). Building health-care partnerships by supporting autonomy: Promoting maintained behavior change and positive health outcomes. In A. L. Suchman, P. Hinton-Walker, & R. Botelho (Ed.), Partnerships in healthcare: Transforming relational process (pp. 67-87). Rochester, NY: University of Rochester Press.

    BACKGROUND
  • Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26. doi: 10.1037//0022-3514.70.1.115.

    PMID: 8558405BACKGROUND
  • Wilson, P. M., Rogers, W. T., Rodgers, W. M., & Wild, T. C. (2006). Psychological need satisfaction in exercise scale. Journal of Sport & Exercise Psychology, 28, 231-251.

    BACKGROUND
  • Price J, Brunet J. Feasibility and acceptability of a telehealth behavior change intervention for promoting physical activity and fruit and vegetable consumption among rural-living young adult cancer survivors. J Psychosoc Oncol. 2021;39(6):715-733. doi: 10.1080/07347332.2021.1896616. Epub 2021 Apr 2.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 1, 2018

Study Start

October 1, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations