Conducting a randomized clinical trial of an psychological intervention for parents/caregivers of children with cancer shortly after diagnosis. Randomized clinical trial of a family intervention for prostate cancer patients and their spouses. Treatment of posttraumatic stress symptoms in adolescent survivors of childhood cancer and their families: a randomized clinical trial. Brief report: an intervention program for parents of pediatric cancer patients: a randomized controlled trial. Group therapy with adolescent cancer patients. An evaluation of the impact of a self-care coping intervention on psychological and clinical outcomes in adolescents with newly diagnosed cancer. Lessons learned: Outcomes and methodology of a coping skills intervention trial comparing individual and group formats for patients with cancer. Intervention to improve psychological functioning for newly diagnosed patients with cancer. Telephone therapy for patients with breast cancer.
To report acceptability, feasibility, and outcome data from a randomized clinical trial (RCT) of a brief intervention for caregivers of children newly diagnosed with cancer.
                Eighty-one families were randomly assigned following collection of baseline data to Intervention or Treatment as Usual (TAU). Recruitment and retention rates and progression through the protocol were tracked. Measures of state anxiety and posttraumatic stress symptoms served as outcomes.
                Difficulties enrolling participants included a high percentage of newly diagnosed families failing to meet inclusion criteria (40%) and an unexpectedly low participation rate (23%). However, movement through the protocol was generally completed in a timely manner and those completing the intervention provided positive feedback. Outcome data showed no significant differences between the arms of the RCT.
                There are many challenges inherent in conducting a RCT shortly after cancer diagnosis. Consideration of alternative research designs and optimal timing for interventions are essential next steps. Few intervention studies have been conducted to help couples manage the effects of prostate cancer and maintain their quality of life. The objective of this study was to determine whether a family-based intervention could improve appraisal variables (appraisal of illness or caregiving, uncertainty, hopelessness), coping resources (coping strategies, self-efficacy, communication), symptom distress, and quality of life in men with prostate cancer and their spouses.
                For this clinical trial, 263 patient-spouse dyads were stratified by research site, phase of illness, and treatment; then, they were randomized to the control group (standard care) or the experimental group (standard care plus a 5-session family intervention). The intervention targeted couples' communication, hope, coping, uncertainty, and symptom management. The final sample consisted of 235 couples: 123 couples in the control group and 112 couples in the experimental group. Data collection occurred at baseline before randomization and at 4 months, 8 months, and 12 months.
                At 4-month follow-up, intervention patients reported less uncertainty and better communication with spouses than control patients, but they reported no other effects. Intervention spouses reported higher quality of life, more self-efficacy, better communication, and less negative appraisal of caregiving, uncertainty, hopelessness, and symptom distress at 4 months compared with controls, and some effects were sustained to 8 months and 12 months.
                Men with prostate cancer and their spouses reported positive outcomes from a family intervention that offered them information and support. Programs of care need to be extended to spouses who likely will experience multiple benefits from intervention.
                2007 American Cancer Society Posttraumatic stress symptoms (PTSS), particularly intrusive thoughts, avoidance, and arousal, are among the most common psychological aftereffects of childhood cancer for survivors and their mothers and fathers. We conducted a randomized wait-list control trial of a newly developed 4-session, 1-day intervention aimed at reducing PTSS that integrates cognitive-behavioral and family therapy approaches--the Surviving Cancer Competently Intervention Program (SCCIP). Participants were 150 adolescent survivors and their mothers, fathers, and adolescent siblings. Significant reductions in intrusive thoughts among fathers and in arousal among survivors were found in the treatment group. A multiple imputations approach was used to address nonrandom missing data and indicated that treatment effects would likely have been stronger had more distressed families been retained. The data are supportive of brief interventions to reduce PTSS in this population and provide additional support for the importance of intervention for multiple members of the family.
                Copyright 2004 American Psychological Association To evaluate a psychoeducational intervention program for parents of pediatric cancer patients, using cognitive and behavioral techniques.
                Parents were randomly assigned to an intervention (n = 39) and a control condition (n = 42). Baseline assessment took place at diagnosis. Short-term effects were measured immediately after the intervention, long-term effects six months later. Control parents received standard care. Intervention parents received, in addition, a manual-guided program during the first six months following the diagnosis.
                With time all parents became significantly less psychologically distressed. However, no between-group differences were noted in psychological functioning, satisfaction with support, and intensity of emotions immediately postintervention and six months later.
                Although the clinical evaluation of the intervention was positive, it appeared that a structured intervention program as described in this study was not any more effective than standard care. This preliminary study assessed the psychologic distress and group psychotherapy of a small group of adolescents and young adults with cancer. A strong relationship was found between the patients' and parents' amount of psychologic distress. It seems that youngsters with cancer in active medical treatment (as well as their parents) use more denial and that psychotherapy increases psychologic distress. The demands of cancer treatment are particularly challenging for newly diagnosed adolescents. If attempts to cope with these demands are unsuccessful, adolescents may not comply with or may refuse treatment. As a result, their chances of survival are decreased. The purpose of this study, guided by the Adolescent Self-Sustaining Model, was to determine the effects of a three-part educational intervention designed to facilitate copying on psychological (hopefulness, hopelessness, self-esteem, self-efficacy and symptom distress) and clinical outcomes (treatment toxicity) among adolescents newly diagnosed with cancer. This two-site study used a longitudinal experimental two-group design with adolescents randomly assigned to the intervention or control group. Four measurement points spanning the first 6 months of treatment were included in the design. Of 93 eligible adolescents, 78 (46 females and 32 males) agreed to participate. No statistically significant differences between the intervention and control groups, or between male and female participants, were detected at any measurement point. Differences in scores over time within groups were noted. Explanations for the lack of group differences are offered, as are recommendations for strengthening the intervention and design for future testing. Nucare, a short-term psychoeducational coping skills training intervention was evaluated in a randomized controlled clinical trial (RCT) of 225 newly diagnosed breast and colon cancer patients.
                Measures of psychosocial distress, well being and optimism were evaluated every four months during a one-year period. Patients were randomized to one of four arms: Nucare presented in an individual basis; Nucare presented in a group format; a non-directive supportive group; and a no-intervention control. The interventions were provided in five sessions of ninety minutes each.
                Patients with breast cancer who received Nucare presented in an individual format showed more significant improvements in well-being over time compared to those in the control and group arms.
                We were unable to develop functioning groups within the RCT. Partial explanations for the latter finding include the structural limitations of the RCT: the groups were small, difficult to schedule and patients indicated that they would have preferred to choose whether or not to participate in a group. The positive changes in women with breast cancer who received Nucare persisted at 12 months. To test the effects of a computer-based nursing intervention designed to provide patients and family caregivers with concrete, objective information on symptom management; provide education about disease and treatment; coordinate medical resources; and provide emotional support and counseling.
                Two-site, randomized clinical trial.
                A large, urban, midwestern, tertiary-cancer center and a community-based cancer center in a medium-sized midwestern city.
                109 patients newly diagnosed with breast, colon, or lung cancer who were receiving chemotherapy; 54 received standard care, and 55 participated in the intervention group.
                Outcome data were collected via structured telephone interviews at three time points: baseline, midway through the intervention, and one month postintervention. The intervention consisting of nine visits, five in person and four by telephone, was conducted over 18 weeks by advanced practice oncology nurses.
                Psychosocial functioning, anxiety, and depression.
                Patients who received the intervention had significantly less depression between baseline and the midway point, as well as less anxiety and greater improvement in the role-emotional and mental health subscales of the Medical Outcomes Study 36 Short Form.
                Cancer-care nursing interventions can decrease psychosocial morbidity and improve quality of life for newly diagnosed patients with cancer undergoing treatment. Additional research is needed to understand who benefited most from the intervention.
                This nurse-directed intervention resulted in improved mental health for patients; however, physical subscales were not changed. Further work is needed to determine why depression and mental health were affected yet physical health and symptoms did not differ between groups. Results support the important role of nurses in addressing mental health issues in patients and families experiencing cancer. To test the value of telephone-administered cognitive-behavioral therapy in a study of patients with breast cancer.
                Women were assigned randomly to a therapy group or an assessment-only control group.
                A tertiary cancer treatment center serving rural areas of North Dakota and Minnesota.
                Women were recruited within three to four months of stage I (n = 27) or stage II (n = 26) breast cancer diagnosis. Age ranged from 30-82 (mean = 51.5 years). Most participants (n = 35) underwent a modified radical mastectomy; 17 underwent a lumpectomy.
                Therapy involved 10 30-minute (or less) telephone sessions. Data that were collected from mailed questionnaires included psychological distress (Profile of Mood States), perceived stress, coping (Coping Response Indices-Revised), quality of life (Medical Outcome Scale), and satisfaction with therapy. Measures were completed at baseline and at 4- and 10-month follow-up intervals.
                Telephone therapy, stress, coping, and quality of life.
                With time, women in the therapy and control groups reported reduced stress and improved quality of life. However, significant reductions in some kinds of distress (anxiety, anger, depression, and confusion) were not observed. Most therapy participants liked the telephone treatment sessions but showed only modest improvement (less anxiety and confusion) compared with women in the control group.
                Most patients reported being comfortable with the telephone therapy and said that they felt better as a result of it. However, the outcome data showed that telephone therapy--as carried out in this study--produced only modest benefits. Researchers need to consider who is best for delivering such therapy.
                Providing telephone therapy to patients with breast cancer has potential benefits, and nurses may be the appropriate professionals to administer the therapy.
Different methods of communicating with children and adolescents about a family member's cancer have not been widely evaluated in controlled trials. There is weak evidence to suggest that some interventions, such as structured group interventions, may lead to improvements in knowledge and understanding, in coping, anxiety, adjustment and wellbeing. More research is needed to investigate the comparative value of these interventions.