ClinicalTrials.gg
CompletedNCT05379933C-PRIMEUpdated Jan 20, 2023

Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life

An interventional study of Remote health coaching to improve self-care behaviors in Stress, Quality of Life and Sleep Disturbance, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-20.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to test an intervention to improve health promoting behaviors in family caregivers of patients receiving cancer therapy

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Conditions studied

  • Stress
  • Quality of Life
  • Sleep Disturbance

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Keywords

  • Family Caregiver
  • Well-being
03

In context

Parasomnias

769 studies on the registry are indexed under Parasomnias; 187 are open to participants now.

This study's enrollment of 33 is below the median of 66 across 579 interventional studies indexed under Parasomnias.

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Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 539 studies on the registry; 74 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Eligible family caregivers will be:
  • An unpaid family member or friend who provides assistance and support with healthcare of a non-institutionalized patient receiving some form of treatment for stage III or IV colorectal cancer at Moffitt Cancer Center
  • Age 18+ years
  • English or Spanish speaking
  • Able to complete questionnaires and engage in short discussions with coaches
  • Able to identify a primary care medical provider
  • Willing/able to use a mobile device provided by the study team or their own their device.

Exclusion criteria

Exclusion Criteria:

  • Participants who do not meet the study inclusion criteria
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    C-PRIME

    Participants will wear an activity tracker for 8 weeks. During the 8 weeks of the study, participants will complete weekly survey questions about health and well-being and engage in weekly, 15-20 minute telephone/videoconference coaching sessions with a health coach.

    Other: Remote health coaching to improve self-care behaviors

Interventions

  • OtherRemote health coaching to improve self-care behaviors

    Participants will be asked to wear an activity tracker, complete brief surveys, and participate in weekly health coaching sessions remotely for 8 weeks

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What researchers measure

Primary outcomes

  1. Percentage of Participants Who Agree to Participate (Acceptability)

    The study will be deemed acceptable if at least 50% of eligible family caregivers agree to participate

    Time frame: 12 Months

  2. Percentage of Participants Who Provide Data (Feasibility)

    The study will be deemed feasible if at least 75% of family caregivers who participate provide data for at least 50% of study days

    Time frame: 12 Months

Secondary outcomes

  1. Self Care Behaviors - Primary Efficacy

    Participant's self care behaviors will be measured using the Health-Promoting Lifestyle Profile-II. This is a 52-item questionnaire that assesses use of behaviors likely to promote a healthy lifestyle and indicate greater selfcare. Responses are categorized into an overall health-promoting lifestyle score as well as subscales assessing health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management.

    Time frame: 8 Weeks

  2. Quality of Life -Secondary Efficacy

    Participants' quality of life will be assessed using the EORT QLQ-C30, a 30-item measure that assesses quality of life in various domains of functioning and symptoms.

    Time frame: 8 Weeks

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Study locations

1 site
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
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References and documents

Publications

  • Gudenkauf LM, Li X, Hoogland AI, Oswald LB, Lmanirad I, Permuth JB, Small BJ, Jim HSL, Rodriguez Y, Bryant CA, Zambrano KN, Walters KO, Reblin M, Gonzalez BD. Feasibility and acceptability of C-PRIME: A health promotion intervention for family caregivers of patients with colorectal cancer. Support Care Cancer. 2024 Feb 28;32(3):198. doi: 10.1007/s00520-024-08395-5. PubMed 38416143 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05379933
Responsible party
Sponsor
First posted
May 18, 2022
Start date
May 11, 2022
Primary completion
Nov 15, 2022
Completion
Nov 15, 2022
Last update
Jan 20, 2023

Study contacts

Brian Gonzalez, PhD
principal investigator · Moffitt Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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