NCT07026214

Brief Summary

This study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of an 8-week, remotely delivered health coaching intervention designed to improve: 1) targeted psychosocial mechanisms of action (behavioral regulation skills, affective attitudes, health habits, and identity); 2) health behaviors (physical activity, diet, sleep); and 3) cancer-related health outcomes (physical function, anxiety, depression, fatigue, and pain) among young and middle-aged adult cancer survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable cancer

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

May 30, 2025

Last Update Submit

June 17, 2025

Conditions

Keywords

health coachingcancer survivorship

Outcome Measures

Primary Outcomes (4)

  • Feasibility - Enrollment

    Enrollment rates calculated as percentage of enrolled vs interested participants

    From the first day of study recruitment until the date of the last participant to complete the intervention, assessed up to 36 months

  • Acceptability

    Participants self-reported their acceptability with each intervention feature using an Acceptability Survey. Responses were collected using a 5 point likert scale with higher numbers representing greater satisfaction (1=Very disatisfied, 5=Very Satisfied)

    Post-intervention (8 weeks)

  • Feasibility Adherence rates

    Participate adherence rates to health coaching sessions calculated as sessions attended vs sessions offered

    From the first day the intervention launched until the date of the last participant to complete the intervention, assessed up to 36 months

  • Feasibility- Retention rate

    Retention rate calculated as percentage comparing number enrolled versus number that complete the study

    From the first day of study recruitment until the date of the last participant to complete the intervention, assessed up to 36 months

Secondary Outcomes (6)

  • Behavioral Regulation Skills

    From enrollment to 8 weeks

  • Habit formation skills

    From enrollment to 8 weeks

  • Physical activity

    Enrollment to 8 weeks

  • Diet behavior

    From enrollment to 8 weeks

  • Sleep behavior

    From enrollment to 8 weeks

  • +1 more secondary outcomes

Study Arms (1)

Vitalis Cancer Intervention

EXPERIMENTAL

The intervention includes health coaching, health education, and wearable activity monitoring.

Behavioral: Vitalis Cancer

Interventions

Vitalis CancerBEHAVIORAL

Participants receive five free health coaching sessions with a trained student health coach, access to three health education videos, and a free wrist worn activity monitor to keep track of their physical activity and sleep behaviors.

Vitalis Cancer Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult cancer survivors aged 18-64 years
  • months post-treatment
  • Not meeting recommendations for physical activity, diet, or sleep.
  • Express interest in improving at least one health behavior.

You may not qualify if:

  • Currently receiving cancer treatment
  • Metastatic disease
  • Pregnancy or plans for pregnancy
  • No access to Zoom or a smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucas J Carr

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 18, 2025

Study Start

January 1, 2023

Primary Completion

June 29, 2023

Study Completion

September 14, 2023

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations