Harvesting Health Program in Improving Diet and Physical Activity Level in Cancer Survivors

NCT ID: NCT02268188

Last Updated: 2019-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-10-31

Brief Summary

This pilot clinical trial studies the Harvesting Health Program in improving the diet and physical activity level of cancer survivors. Nutrition and physical activity classes and the opportunity to harvest fruits, vegetables, and herbs may increase participants' fruit and vegetable consumption and physical activity levels. Studying the participation rates and changes in participants' eating and physical activity habits may help doctors learn whether the program has an effect on participant lifestyle.

Detailed Description

PRIMARY OBJECTIVES:

I. Measure survivor participation in regards to each aspect of the Harvesting Health Program (personalized and group education, gardening and harvesting, and utilization of novel web-based technologies).

II. Assess survivor preferences regarding key Harvesting Health Program components impacting participation (physical facilities, schedule and timing, education topics and sessions, garden access, web portal usability, etc.).

SECONDARY OBJECTIVES:

I. A customized "Nutrition & Physical Activity Scorecard" has been developed and will be implemented to evaluate pre/post measures of diet and physical activity at baseline (month 0) and at months 6, 9 and 12.

II. Participants are evaluated at baseline and at completion of the intervention for: (a) serum and body composition biomarkers of exposure and efficacy, and (b) health indices related to cancer survivorship and overall health.

III. To assess Program sustainability, follow-up questionnaires will be completed at 9 and 12 months using the Nutrition & Physical Activity Scorecard and questionnaires regarding quality of life outcomes.

OUTLINE:

Participants undergo a series of 10 education and training sessions over 1 hour every 2 weeks, comprising education on current research, evidence-based health guidelines, application techniques, reference materials specific to extended-stage cancer survivors, and recommendations and personal health goals for survivorship.

Conditions

Cancer Survivor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive Care (Harvesting Health program)

Participants undergo a series of 10 education and training sessions over 1 hour every 2 weeks, comprising education on current research, evidence-based health guidelines, application techniques, reference materials specific to extended-stage cancer survivors, and recommendations and personal health goals for survivorship. The guidelines described in class are part of a nutrition intervention and an exercise intervention with personal and group goal setting over the course of the study.

Group Type: EXPERIMENTAL

education

Intervention Type: OTHER

Attend classes as part of Harvesting Health program

nutrition intervention

Intervention Type: OTHER

Learn how to incorporate nutrition guidelines into daily meal plans as part of Harvesting Health program

exercise intervention

Intervention Type: BEHAVIORAL

Use FitBit to log daily steps as part of Harvesting Health program

questionnaire administration

Intervention Type: OTHER

Ancillary studies

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

quality-of-life assessment

Intervention Type: OTHER

Ancillary studies

Interventions

education

Attend classes as part of Harvesting Health program

Intervention Type: OTHER

nutrition intervention

Learn how to incorporate nutrition guidelines into daily meal plans as part of Harvesting Health program

Intervention Type: OTHER

exercise intervention

Use FitBit to log daily steps as part of Harvesting Health program

Intervention Type: BEHAVIORAL

questionnaire administration

Ancillary studies

Intervention Type: OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

quality-of-life assessment

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

quality of life assessment

Eligibility Criteria

Inclusion Criteria

• Voluntary agreement to participate and sign an informed consent document
• Adults with the ability to read, write, and speak English who have access to the internet
• Cancer survivors who have completed active cancer treatments within the previous 12 months extended-stage survivors)
• Survivors must have a computer with internet access and an active email account
• Participants must refrain from traveling for more than 3 weeks total during the intervention period
• Participants who are undergoing long-term hormone therapy (i.e., tamoxifen) are permitted to enroll

Exclusion Criteria

• Cancer survivors who are cognitively unable to consent or have physical or mental limitations that would prevent full participation in the program
• Adults receiving active treatment including surgery, neoadjuvant hormonal, chemotherapy, or radiation
• Survivors with pre-existing medical conditions that preclude unsupervised physical activity (i.e., severe orthopedic conditions, impending hip or knee replacement, paralysis, unstable angina, dementia, or recent history of myocardial infarction, congestive heart failure, pulmonary conditions that require oxygen, or hospitalization within six months)
• Adults taking any medication that do not allow for increased intake of fruits and vegetables (i.e., pharmacologic doses of warfarin)
• Survivors currently involved in other clinical trials
• Long-term cancer survivors (> 12 months post treatment)
• Those planning to start certain medications after the trial enrollment or use of non- prescription substances (i.e. saw palmetto and other herbal or alternative products)
• Survivors with active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, celiac disease, irritable bowel syndrome [IBS]), renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome
• Pregnant women will be excluded from the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Steven Clinton

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Clinton

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

References

Spees CK, Braun AC, Hill EB, Grainger EM, Portner J, Young GS, Kleinhenz MD, Chitchumroonchokchai C, Clinton SK. Impact of a Tailored Nutrition and Lifestyle Intervention for Overweight Cancer Survivors on Dietary Patterns, Physical Activity, Quality of Life, and Cardiometabolic Profiles. J Oncol. 2019 Nov 21;2019:1503195. doi: 10.1155/2019/1503195. eCollection 2019.

Reference Type: DERIVED

PMID: 31871455 (View on PubMed)

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2014-01498

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-14013

Identifier Type: -

Identifier Source: org_study_id