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Completed

NCT Number: NCT00822510

Telephone Counseling: Men With Prostate Cancer & Partners

The purpose of this project is to test a telephone delivered educational support program versus an education only program for improving symptom management and quality of life in men with prostate cancer and their partners.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Arizona

Tucson, Arizona, 85721, United States

About this study

Eligibility Criteria for men: receiving treatment for prostate cancer,over 21 years of age, English speaking, have access to and ability to talk on the phone and have a partner willing to participate in the study. Participants can live anywhere in the United States because the intervention is telephone delivered.

Partners can be anyone the man selects (friend or relative) who is over 21 years of age, English speaking and has access to or ability to speak on the phone.

Men and their partners will be assigned to one of two groups. Each survivor will receive 8 telephone calls over an 8-week period for about 30 minutes each. Each partner will receive 4 telephone calls every other week for about 30 minutes each. We will ask everyone to complete a baseline assessment over the telephone, after the 8 weeks, and then again about 8 weeks after the second assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Receiving treatment for prostate cancer
  • Over 21 years
  • Access to and ability to talk on the phone
  • Speaks English and has a partner to participate with him.
  • Partners are anyone who the man chooses (friend or relative) who is over 21 years, English speaking and has access and ability to talk on the phone.

Exclusion criteria

  • under 21 years
  • Does not speak English

Treatment and study plan

Telephone Interpersonal Counseling

Behavioral

Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy.

Telephone delivered education only

Behavioral

Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation

Primary outcomes

  1. Center for Epidemiological Studies-Depression Scale

    Time frame: 3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks

    Depression was measured by the 20-item Center for Epidemiological Studies-Depression (CES-D) scale, Range is 0-60. Scores are added together with higher score greater depression.

  2. Perceived Stress

    Time frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)

    Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress.

  3. Positive Affect

    Time frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)

    Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.

  4. Negative Affect

    Time frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)

    Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.

  5. Multidimensional Fatigue Inventory

    Time frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)

    Measure of physical well-being, specifically fatigue, using the Multidimensional Fatigue Scale. Scores range from 0-80 with higher scores indicative of more fatigue.

  6. Social Well Being

    Time frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)

    Measures social well-being using the 9 item Social Well-being scale, ranging from 9-90. Higher score indicates increased social well-being.

  7. Spiritual Well Being

    Time frame: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)

    Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Telephone Counseling With Men With Prostate Cancer and Partners

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 14, 2009
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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