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

NCT02268188 | Completed DMC

• 2 other identifiers: OSU-14013NCI-2014-01498
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivor

Keywords

Cancer Survivors

Outcome Measures

Primary Outcomes (2)

• Percentage of sessions attended, as measured by mobile scanner

  Analyzed with standard descriptive statistics. Measures of central tendency (mean and/or median) and spread (standard deviation, quartiles, minimum and maximum) will be reported.

  Up to 6 months

• Number of hits on the web portal

  Analyzed with standard descriptive statistics. Measures of central tendency (mean and/or median) and spread (standard deviation, quartiles, minimum and maximum) will be reported.

  Up to 12 months

Secondary Outcomes (6)

• Number of web hits on portal pages

  Up to 12 months

• Program evaluation overall score

  Up to 20 weeks

• Change in behavior, measured by Nutrition & Physical Activity Scorecards

  Baseline to 12 months

• Change in biomarker levels, assessed by values for the Health & Wellness Index

  Baseline to 6 months

• Change in physical activity using the International Physical Activity Questionnaire

  Baseline to 12 months

Other Outcomes (2)

• Change in Quality of Life using the Short Form-12 (SF-12)

  Baseline to 6 months

• Change in depression scale using the Center for Epidemiologic Studies Depression Scale Revised (CED-R)

  Baseline to 6 months

Study Arms (1)

Supportive Care (Harvesting Health program)

EXPERIMENTAL

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.

Other: education; Other: nutrition intervention; Behavioral: exercise intervention; Other: questionnaire administration; Other: laboratory biomarker analysis; Other: quality-of-life assessment

Interventions

education OTHER

Attend classes as part of Harvesting Health program

Supportive Care (Harvesting Health program)

nutrition intervention OTHER

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

Supportive Care (Harvesting Health program)

exercise intervention BEHAVIORAL

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

Supportive Care (Harvesting Health program)

questionnaire administration OTHER

Ancillary studies

Supportive Care (Harvesting Health program)

laboratory biomarker analysis OTHER

Correlative studies

Supportive Care (Harvesting Health program)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Supportive Care (Harvesting Health program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 31871455 DERIVED

Related Links

• The Jamesline

MeSH Terms

Interventions

Educational Status; Diet Therapy

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Nutrition Therapy; Therapeutics

Study Officials

• Steven Clinton

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 20, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 31, 2015
• Last Updated: August 30, 2019

Record last verified: 2019-08

Locations

US (1)