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CompletedNCT00932997Updated Oct 1, 2026

Survivorship Booklets With or Without Individual Telephone Sessions in Increasing Knowledge About the Impact of Breast Cancer in African American and Latina Breast Cancer Survivors

An interventional study of telephone-based intervention and counseling intervention in Breast Cancer, Cancer Survivor and Psychosocial Effects of Cancer and Its Treatment, sponsored by City of Hope Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 5 years 1 month after the study started (first participant enrolled May 2004, registered Jul 2009).
Updated Oct 1, 2026Start date movedEligibility revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
Female
01

Study summary

RATIONALE: Telephone sessions and survivorship booklets may increase knowledge about the psychological and physical impact of breast cancer and increase awareness of available resources. It is not yet known whether survivorship booklets are more effective when given alone or together with individual telephone sessions in informing breast cancer survivors.

PURPOSE: This randomized clinical trial is studying individual telephone sessions given together with survivorship booklets compared with survivorship booklets alone to see how well they work in increasing knowledge about the impact of breast cancer in African American and Latina breast cancer survivors.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate the utility of individual telephone sessions plus survivorship booklets versus the survivorship booklets alone in increasing knowledge about the psychological and physical impact of breast cancer and increasing awareness of appropriate psychological and medical resources among African American and Latina breast cancer survivors.
  • Evaluate the utility of these interventions in improving psychological functioning (depression and anxiety) among breast cancer survivors.
  • Evaluate the utility of these interventions in improving family and social functioning (changes in family and partner communications) among breast cancer survivors.

Secondary

  • Evaluate predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) within and across breast cancer survivors ethnic groups to identify both general and ethnic-specific correlates.

OUTLINE: Patients are stratified according to ethnicity (African American vs Latina). Patients are randomized to 1 of 2 groups.

  • Group 1: Patients receive a survivorship kit of booklets in English or Spanish. Patients then receive a follow-up telephone call at approximately 2 months to clarify any issues relevant to the survivorship kit of booklets.
  • Group 2: Patients participate in 8 weekly telephone sessions addressing basic breast cancer information; education about psychological and medical effects of cancer and its treatments; resources including psychosocial, medical care facilities, and clinical trials information; stress management and relaxation; cognitive reframing of concerns and behavioral strategies; family communication; relational communication and intimacy; and social support. Patients also receive a survivorship kit of booklets as in group 1.

After completion of study intervention, patients complete follow-up questionnaires at 4 to 6 months.

02

Conditions studied

  • Breast Cancer
  • Cancer Survivor
  • Psychosocial Effects of Cancer and Its Treatment

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Keywords

  • psychosocial effects of cancer and its treatment
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • cancer survivor
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 300 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with breast cancer within the past 1-5 years

    • Stage I-IIIA disease
  • No metastatic disease

PATIENT CHARACTERISTICS:

  • No other major disabling medical (e.g., another cancer, stroke, heart disease) or psychiatric conditions
  • Self-identified ethnically as African-American or Latina
  • Able to read and/or speak English or Spanish
  • No severe depression or anxiety

    • History of mild to moderate depression or anxiety allowed
  • Not pregnant
  • Not incarcerated

PRIOR CONCURRENT THERAPY:

  • Any type of prior anticancer therapy allowed
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Interventions

  • Behavioraltelephone-based intervention

    Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey

  • Othercounseling intervention

    Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey

  • Othereducational intervention

    Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey

  • Otherquestionnaire administration

    Baseline and 9 months after enrollment and intervention

  • Procedurepsychosocial assessment and care

    Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey

  • Procedurequality-of-life assessment

    Baseline and 9 months after enrollment and intervention

06

What researchers measure

Primary outcomes

  1. Increased knowledge about the psychological and physical impact of breast cancer

    Time frame: 9 months post study enrollment

  2. Improved psychological functioning (depression and anxiety)

    Time frame: 9 months post study enrollment

  3. Improved family and social functioning (changes in family and partner communications)

    Time frame: 9 months post study enrollment

Secondary outcomes

  1. Predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors)

    Time frame: 9 months post study enrollment

07

Study locations

1 site
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010-3000, United States
08

Updates

1 registry update since Sep 25, 2026
Start date
Oct 2006→May 8, 2004 (actual)
Oct 1, 2026
Also revised
eligibility
Show all 1 update
  1. Oct 1, 2026
    Start date Oct 2006→May 8, 2004 (now actual)
    Eligibility Maximum age none→120 Years
    + 4 other changes: index terms, verification date, design details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT00932997
Lead sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 7, 2009
Start date
May 8, 2004
Primary completion
Jun 1, 2010
Completion
Jun 1, 2010
Last update
Oct 1, 2026

Study contacts

Kimlin Ashing-Giwa, PhD
principal investigator · City of Hope Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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