Living Well on Androgen Deprivation Therapy

NCT02108613 | Withdrawn DMC

• 1 other identifier: 084902
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately half of men treated for prostate cancer will be offered hormone deprivation therapy during their cancer experience. The secondary effects of this treatment can result in osteoporosis, cardiovascular disease, stroke, diabetes, and diminished sexual health. To promote healthy lifestyle choices for couples and maintain their intimacy and emotional health we propose the Living Well, an innovative program that combines nutrition, physical activity, and sexual health initiatives in one integrated service. This project will be piloted at the Vancouver Island Centre with an expected 100 patients over 1 year. Over a six month period both the experimental and control groups will have access to a workbook (designed for men with prostate cancer and on hormone deprivation therapy) and sexual health counseling. The experimental group will also have access to an exercise and a nutritional program and support by volunteers to keep motivated. Assessment will look at quality of life, physical factors, and biomarkers associated with secondary disease.

Conditions

Prostate Cancer

Keywords

Androgen deprivation therapy; Supportive care; Quality of life

Outcome Measures

Primary Outcomes (3)

• Change from baseline in participant's quality of life on the Functional Assessment of Chronic Illnesses Therapy (FACT-P)

  Functional Assessment of Chronic Illnesses Therapy is a quality of life questionnaire for patients.with prostate cancer.

  Baseline, 6 months, 12 months and 24 months

• Change from baseline in patient's partner quality of life on the Quality of Life Scale (QOLS)

  The Quality of Life Scale is a quality of life questionnaire that will be used for participants partners.

  Baseline, 6 months,12 months, 24 months

• Change from baseline in fatigue on the Functional Assessment of Chronic Illnesses Therapy- Fatigue (FACIT-fatigue)

  The Functional Assessment of Chronic Illnesses Therapy is a measure of fatigue. This outcome will be tested for both participants and their partners.

  Baseline, 6 months, 12 months, 24 months

Secondary Outcomes (1)

• Change from baseline in intimacy on the Dyadic Adjustment Scale (DAS)

  Baseline, 6 months, 12 months, 24 months

Other Outcomes (9)

• Change from baseline in Body-Mass Index

  Baseline, 3 months, 6 months, 12 months and 24 months

• Change from baseline in waist circumference

  Baseline, 3 months, siz months, 12 months and 24 months

• Change from baseline in grip strength

  Baseline, 3 months, 6 months, 12 months and 24 months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention arm will receive sexual health counselling, exercise sessions, nutrition education, and will be assigned a peer support volunteer.

Behavioral: Exercise Sessions; Behavioral: Nutrition Education; Behavioral: Peer Support Volunteer

Control

NO INTERVENTION

The control group will receive sexual health counseling.

Interventions

Exercise Sessions BEHAVIORAL

8 weeks of weekly exercise classes taught by a certified exercise physiologist.

Intervention

Nutrition Education BEHAVIORAL

Four monthly education sessions on nutrition topics. Presentations and materials are were created by a BCCA dietitian.

Intervention

Peer Support Volunteer BEHAVIORAL

Participants will be assigned a peer support volunteer who will preform adherence calls to discuss goals and motivations about improving exercise and healthy eating.

Intervention

Eligibility Criteria

• Age: Up to 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All prostate cancer patients registered with BCCA-VIC or referred by an urologist that are prescribed to receive androgen deprivation in their care plan (not currently on hormone therapy)
• Must provide written, informed consent
• Must be able to understand, speak, read and write English, and have the cognitive capacity to complete written questionnaires
• Must be deemed ready to become more physically active, as determined by the PAR-Q+ and, if required, screened by a Canadian Society for Exercise Physiology Certified Exercise Physiologist® (CSEP-CEP) or medical doctor.
• Must be willing and able to attend the introductory meeting with the Prostate Centre nurse (baseline measurement recordings), 8 weeks of supervised exercise, 4 monthly nutrition meetings, two sexual health meetings (which includes measurement recording sessions at 6 months), and follow up at 12 and 24 months
• Must have access to a telephone
• Must be able to commit to the full 6 month intervention period of the study (i.e. no scheduled, extended absences) and follow up at 12 and 24 months. This does not preclude any participants from withdrawing from the study at any point.
• Must have greater than 12 months life expectancy

You may not qualify if:

• Prior invasive malignancy (except non-melanomatous skin cancer) or superficial bladder cancer unless disease free for a minimum of 5 years \[for example, carcinoma in situ of the oral cavity is permissible\]
• Previous hormone therapy within the past 5 years
• Participants who do not meet the following PAR-Q+(26, 27) criteria will be excluded from the study:
• Must not have a YES response to Q2 on pg1: Do you feel pain in your chest at rest, during your daily activities of living, OR when you do physical activity?
• Must not have a YES response to Q7 on pg 1: Has your doctor ever said that you should only do medically supervised physical activity?
• Must not have YES response to any sub-questions on pages 2-3 related to musculoskeletal conditions, diabetes, heart disease, mental health problems or learning difficulties, pulmonary conditions, spinal cord injury, stroke unless clearance is provided by a CSEP-CEP . A CSEP-CEP will only provide clearance to a positive response if upon further query it is determined that the participant is asymptomatic and the benefits of light to moderate intensity exercise outweigh any foreseeable health and injury risks. In such cases where the CSEP-CEP makes a professional determination that the foreseeable risks may outweigh the benefits of exercise or the participant does not know the necessary details of his or her own medical condition, then the participant will need to obtain clearance via the physician referral letter.
• PARQ+ form must be signed and dated within 6 months of entry into study
• More than 80 years of age

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• The Prostate Centre - Vancouver Island and the Gulf Islands: collaborator

Study Sites (1)

BC Cancer Agency

Victoria, British Columbia, V*R 6V5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Jennifer Goulart, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

• Satnam Sidhu, RD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 9, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2017
• Last Updated: July 29, 2021

Record last verified: 2014-04

Locations

CA (1)