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Remote Monitoring With Health-Coaching for Lifestyle Changes in Patients With Lung Cancer Related Fatigue

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05407038
Collaborator
National Cancer Institute (NCI) (NIH)
30
Enrollment
1
Location
1
Arm
15
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial investigates the effectiveness of a remote monitoring program for lifestyle changes in patients with lung cancer related fatigue (CRF). Fatigue is a common symptom of lung cancer and a side-effect of cancer treatments. CRF has a negative impact on patients' quality of life, daily activities, employment, social relationships and mood. Health coaches enable patients to develop and achieve self-determined wellness goals and assist patients to use their insight, personal strengths, goal setting, action steps, and accountability toward achieving healthy lifestyle changes. Remote monitoring with health-coaching may help relieve lung cancer related fatigue and increase the quality of life in cancer patients.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise Counseling
  • Other: Exercise Intervention
  • Other: Internet-Based Intervention
  • Other: Interview
  • Other: Medical Device Usage and Evaluation
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. To assess the effect of the remote-monitoring program on patient reported fatigue by administering the Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy Fatigue (FACT-F), Functional Assessment of Cancer Therapy- Lung (FACT-L) and the Modified Fatigue Impact Scale (MFIS).
OUTLINE:

Patients undergo routine exercise using a remote monitoring system (Garmin Vívofit activity monitor, Nonin 3150 WristOx2 pulse oximeter, and an Android tablet) over 30 minutes at least 6 days per week and complete daily questionnaires over 20 minutes for 12 weeks. Patients also receive health coaching telephone calls over 5-20 minutes once a week for 12 weeks. At the end of the 12 weeks, patients complete an audio taped telephone interview.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Remote Monitoring With Health-Coaching for Lifestyle Changes in Patients With Lung Cancer Related Fatigue
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive care (remote monitoring with health coaching)

Patients undergo routine exercise using a remote monitoring system (Garmin Vívofit activity monitor, Nonin 3150 WristOx2 pulse oximeter, and an Android tablet) over 30 minutes at least 6 days per week and complete daily questionnaires over 20 minutes for 12 weeks. Patients also receive health coaching telephone calls over 5-20 minutes once a week for 12 weeks. At the end of the 12 weeks, patients complete an audio taped telephone interview.

Other: Exercise Counseling
Receive call from health coach

Other: Exercise Intervention
Undergo routine exercise

Other: Internet-Based Intervention
Receive Android tablet

Other: Interview
Complete a qualitative interview

Other: Medical Device Usage and Evaluation
Wear Garmin Vivofit and Nonin 3150 WristOx2 pulse oximeter

Other: Questionnaire Administration
Ancillary studies

Outcome Measures

Primary Outcome Measures

  1. Fatigue [Baseline to 3 months]

    The BFI is a nine item questionnaire with a 10 point numeric scale measuring fatigue level and it's interference with daily life. The higher the score the more fatigue.

Secondary Outcome Measures

  1. Quality of life fatigue assessement [Baseline to 3 months]

    The functional assessment is a 50 item questionnaire that measures self-reported fatigue and its impact on daily living using a Likert scale from Not at all (0) to Very Much (4).The higher the score the more symptoms interfere with daily living.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Diagnosed with advanced lung non-small cell carcinoma (NSCLC) being treated with any line of non-curative intent, systemic treatment.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to

  • The ability to read and respond to questions in English or Spanish

  • Receiving primary cancer care at Mayo Clinic, Rochester or Mayo Clinic Health System (MCHS).

  • Age > 18 years.

  • Life expectancy at least 6 months.

  • Moderate or higher fatigue (>= 4) on a scale of 0-10 based on fatigue rating to question: Rate your average fatigue over the last week, where 0 is no fatigue and 10 is extreme fatigue.

Exclusion Criteria:
  • They have cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Roberto P Benzo, Mayo Clinic in Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05407038
Other Study ID Numbers:
  • 21-013228
  • NCI-2022-02155
  • 21-013228
  • P30CA015083
First Posted:
Jun 7, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Aug 5, 2022