Brief Summary

To date, few interventions have been designed specifically to promote physical activity in young adult cancer survivors, nor used novel technologies for delivery; none have been successful in promoting long-term adherence to PA. The purpose of this randomized controlled trial is to test the efficacy of a theory-based, mobile physical activity intervention with adaptive goal-setting and tailored feedback that is aimed at increasing physical activity among young adult cancer survivors.

Trial Health

On Track

Trial Health Score

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

Enrollment

280

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Aug 2018

Typical duration for not_applicable

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

2.4 years study duration

First Submitted

Initial submission to the registry

May 21, 2018

Completed

1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed

2 months until next milestone

Study Start

First participant enrolled

August 23, 2018

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed

Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

2.4 years

First QC Date

May 21, 2018

Last Update Submit

March 30, 2021

Conditions

Physical Activity Neoplasms Neoplasms by Site Cancer

Keywords

young adultcancer survivor

Outcome Measures

Primary Outcomes (1)

Minutes of total physical activity at 6 months: objective
Change in objective levels of physical activity, as measured by accelerometry (ActiGraph), from baseline to 6 months. Participants will wear an accelerometer on their wrist during a 7 day period.
Baseline, 6 months

Secondary Outcomes (17)

Minutes of total physical activity at 6 months: self-report
Baseline, 6 months
Minutes of total physical activity at 12 months: objective
Baseline, 6 months, 12 months
Minutes of total physical activity at 12 months: self-report
Baseline, 6 months, 12 months
Minutes of light-intensity physical activity: objective
Baseline, 6 months, 12 months
Minutes of light-intensity physical activity: self-report
Baseline, 6 months, 12 months
+12 more secondary outcomes

Other Outcomes (4)

Mood
Baseline, 3 months, 6 months, 12 months
Depressive symptoms
Baseline, 3 months, 6 months, 12 months
Adherence to physical activity monitoring
Through study completion, 12 months
+1 more other outcomes

Study Arms (2)

Self-help

ACTIVE COMPARATOR

Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group.

Behavioral: Intervention

Intervention

EXPERIMENTAL

Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group, behavioral lessons, adaptive physical activity goals, tailored feedback summaries, and text messages.

Behavioral: Self-help

Interventions

Self-helpBEHAVIORAL

Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group.

Also known as: Digital tools

Intervention

InterventionBEHAVIORAL

Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group with the addition of behavioral lessons, adaptive physical activity goals, tailored feedback summaries, and text messages.

Also known as: Digital tools plus

Self-help

Eligibility Criteria

Age18 Years - 39 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Currently age 18-39
Diagnosed with invasive malignancy between the ages of 18-39 years
Diagnosed with invasive malignancy in the last 10 years with no evidence of progressive disease or second primary cancers
Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention), except may be receiving "maintenance" therapy to prevent recurrences
Have the ability to read, write and speak English
No pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
Not adhering to the American College of Sports Medicine recommendation of at least 150 moderate-to-vigorous physical activity minutes/week
Have access to the Internet on at least a weekly basis
Possession and usage of an Internet e-mail address or willingness to sign up for a free email account (e.g., gmail)
Have mobile phone with text messaging plan
Willing to be randomized to either arm
Successful completion of accelerometer-assessed activity (i.e., at least 10 hours/day on 4 of 7 days) and return of the accelerometer in a pre-paid envelope at baseline

You may not qualify if:

History of heart attack or stroke within past 6 months
Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by their health care provider
Health problems which preclude ability to walk for physical activity
Report a diagnosis of psychiatric diseases (schizophrenia, bipolar disorder, depression leading to hospitalization in the past year), drug or alcohol dependency.
Report a past diagnosis of or treatment for a DSM-IV-TR eating disorder (anorexia nervosa or bulimia nervosa)
Current participation in another physical activity or weight control program
Currently using prescription weight loss medications
Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
Currently exercising \> 150 minutes/week of moderate-to-vigorous intensity physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

UNC Lineberger Comprehensive Cancer Centerlead
University of South Carolinacollaborator
National Cancer Institute (NCI)collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (4)

Valle CG, Heiling HM, Deal AM, Diamond MA, Hales DP, Nezami BT, Rini CM, Pinto BM, LaRose JG, Tate DF. Examining sociodemographic and health-related characteristics as moderators of an mHealth intervention on physical activity outcomes in young adult cancer survivors. J Cancer Surviv. 2025 Oct;19(5):1611-1622. doi: 10.1007/s11764-024-01577-4. Epub 2024 Apr 12.
PMID: 38607515DERIVED
Valle CG, Diamond MA, Heiling HM, Deal AM, Hales DP, Nezami BT, Pinto BM, LaRose JG, Rini CM, Tate DF. Effect of an mHealth intervention on physical activity outcomes among young adult cancer survivors: The IMPACT randomized controlled trial. Cancer. 2023 Feb 1;129(3):461-472. doi: 10.1002/cncr.34556. Epub 2022 Nov 29.
PMID: 36444676DERIVED
Valle CG, Camp LN, Diamond M, Nezami BT, LaRose JG, Pinto BM, Tate DF. Recruitment of young adult cancer survivors into a randomized controlled trial of an mHealth physical activity intervention. Trials. 2022 Apr 4;23(1):254. doi: 10.1186/s13063-022-06148-5.
PMID: 35379294DERIVED
Valle CG, Pinto BM, LaRose JG, Diamond M, Horrell LN, Nezami BT, Hatley KE, Coffman EM, Polzien K, Hales DP, Deal AM, Rini CM, Rosenstein DL, Tate DF. Promoting physical activity in young adult cancer survivors using mHealth and adaptive tailored feedback strategies: Design of the Improving Physical Activity after Cancer Treatment (IMPACT) randomized controlled trial. Contemp Clin Trials. 2021 Apr;103:106293. doi: 10.1016/j.cct.2021.106293. Epub 2021 Jan 27.
PMID: 33515784DERIVED

MeSH Terms

Conditions

Motor ActivityNeoplasmsNeoplasms by Site

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

Carmina G. Valle, PhD, MPH
University of North Carolina, Chapel Hill
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 21, 2018

First Posted

June 26, 2018

Study Start

August 23, 2018

Primary Completion

January 29, 2021

Study Completion

January 29, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (17)

Other Outcomes (4)

Study Arms (2)

Self-help

Intervention

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations