Taking Time to Connect: A Study of Programs for Hispanic Mothers Diagnosed With Cancer and Their Children
Condition: Cancer Survivorship
Study type: Interventional

Summary: 
      This NCI-funded randomized clinical trial (RCT) will test the short-term efficacy of
      Conexiones, a culturally adapted cancer education program designed to help Hispanic mothers
      diagnosed with cancer and their children to cope with cancer.
    

Detailed description: 
      The purpose of the proposed study is to test the short-term efficacy of a cancer parenting
      education program for diagnosed child-rearing Hispanic mothers, called Conexiones. This
      program was culturally adapted from a parenting program previously tested for efficacy in a
      Phase III, 6-state randomized clinical trial. However, the original program was tested on
      primarily non-Hispanic White (NHW) mothers with breast cancer. The Conexiones program
      represents a culturally adapted version of the original parenting program and is now ready
      for testing with Hispanic mothers living in the Border States of New Mexico and Texas.
      Eligible women will be diagnosed within the last 2 years with a primary, non-advanced cancer
      (stages 0-III) of any type and will be mothers of a child 5-17 years of age. Study
      participants will be recruited from medical providers, local channels (e.g. community health
      agencies, Community Health Worker networks, social media), and through self-referral in the
      recruitment counties. After completing signed informed consent and baseline measures, mothers
      will be randomized to an experimental or control group. All program materials/delivery are
      available in English and Spanish. All program education and data collection is conducted
      entirely by telephone so that the women can participate within the comfort of their homes and
      at times convenient for them. The experimental group will receive 5 fully scripted
      telephone-delivered educational sessions every 2 weeks by specially trained patient
      educators. The control group will receive "Taking Time," a NCI cancer education booklet, and
      1 scripted telephone-delivered session with a patient educator. Assessments will occur at 3
      months post-baseline for all participants and at 6 months post-baseline for 66% of
      participants. Post-intervention measures consist of standardized questionnaires with
      well-established validity and reliability, all available in Spanish. Linear Mixed Models will
      be used to analyze outcomes within an intent to treat analysis.. With an estimated Effect
      size of 0.52 for the primary outcome measure of the child's behavioral-emotional adjustment,
      the investigators need to retain a total sample size of 116 (58/group) for efficacy analysis.
      The investigators plan to enroll 156 eligible mothers, allowing for an expected 25% attrition
      rate from all causes. Study results will be essential as a next step in testing Conexiones
      with other Hispanic subgroups in a larger trial and readying the program for wider testing
      and dissemination to provider and non-profit organizations serving Hispanic parents with
      cancer throughout the United States.
    

Intervention name(s): Conexiones; Taking Time
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 5 Conexiones telephone sessions; 1 Taking Time telephone session
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental group: Experimental subjects will receive Conexiones, a program designed to help the cancer-diagnosed mother manage her child's cancer-related concerns by improving the mother's mood and anxiety and by equipping the mother with parenting and communication skills to assist the child in coping with the mother's cancer. The program involves 5 fully scripted telephone-delivered educational sessions delivered at 2-week intervals by patient educators.
Control group: Control subjects will receive an informational booklet published by NCI called, "Taking Time." The booklet contains information on ways to manage emotional issues, including the importance of sharing feelings about the cancer with a trusted adult confidant, learning all you can about your cancer in order to regain control and talking with medical providers, and dealing with a new self-image. This group receives one scripted telephone-delivered session guiding the mother on how to obtain the most from the booklet.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: maternal; non-metastatic; anxiety; depression