Prostate CancerPhase 1NCT00822510
Telephone Counseling: Men With Prostate Cancer & Partners
A Phase 1 study testing Telephone Interpersonal Counseling and Telephone delivered education only in people with Prostate Cancer, run by University of Arizona at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Telephone Interpersonal Counseling and Telephone delivered education only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Oct 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- under 21 years
- Does not speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telephone Counseling With Men With Prostate Cancer and 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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- Telephone Interpersonal Counseling, Telephone delivered education only
- Keywords
- Psychosocial Intervention, Men with Prostate Cancer & Partners
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Interpersonal CounselingBehavioural
Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy.
Telephone delivered education onlyBehavioural
Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Telephone Interpersonal Counseling | Experimental | Telephone delivered interpersonal counseling support intervention. Intervention was for 8 weeks. Participants were called on the telephone each week for about 30 minutes. Receives: Behavioral: Telephone Interpersonal Counseling |
| Telephone delivered education only | Active comparator | Telephone delivered education only. Educational topics included prostate cancer health, side effects, physical activity, diet. Participants were called on the telephone each week for about 30 minutes. Receives: Behavioral: Telephone delivered education only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiological Studies-Depression Scale
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.
Measured: 3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks
Perceived Stress
Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress.
Measured: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Positive Affect
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.
Measured: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Negative Affect
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.
Measured: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Multidimensional Fatigue Inventory
Measure of physical well-being, specifically fatigue, using the Multidimensional Fatigue Scale. Scores range from 0-80 with higher scores indicative of more fatigue.
Measured: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Social Well Being
Measures social well-being using the 9 item Social Well-being scale, ranging from 9-90. Higher score indicates increased social well-being.
Measured: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Spiritual Well Being
Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing.
Measured: 3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startSep 2006
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Terry Badger, University of Arizona
- Investigators
- Terry Badger, PhD, RN, Principal investigator, University of Arizona College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822510
- Sponsor's protocol ID
- 04-0376-02
- Other IDs
- R21CA113409
- Status last verified
- Jun 2016
- First submitted
- 12 Jan 2009
- Last updated
- 11 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Counseling With Men With Prostate Cancer and Partners
- ClinicalTrials.gov ID
- NCT00822510
- Acronym / sponsor ID
- 04-0376-02
- Conditions
- Prostate Cancer
- Keywords
- Psychosocial Intervention, Men with Prostate Cancer & Partners
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Posted 23 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Interpersonal Counseling | Experimental | Behavioral: Telephone Interpersonal CounselingTelephone delivered interpersonal counseling support intervention. Intervention was for 8 weeks. Participants were called on the telephone each week for about 30 minutes. |
| Telephone delivered education only | Active comparator | Behavioral: Telephone delivered education onlyTelephone delivered education only. Educational topics included prostate cancer health, side effects, physical activity, diet. Participants were called on the telephone each week for about 30 minutes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- under 21 years
- Does not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone Interpersonal CounselingTelephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy. | Behavioural | Telephone Interpersonal Counseling |
| Telephone delivered education onlyTelephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation | Behavioural | Telephone delivered education only |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- College of Nursing WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Badger, PhD, RN principal investigator
University of Arizona College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telephone Interpersonal Counseling and Telephone delivered education only in people with Prostate Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center for Epidemiological Studies-Depression Scale (time frame: 3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.