Conducting a randomized clinical trial of an psychological intervention for parents/caregivers of children with cancer shortly after diagnosis.
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Stehl
Meredith Lutz
ML
Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA 19104-4399, USA.
Kazak
Anne E
AE
Alderfer
Melissa A
MA
Rodriguez
Alyssa
A
Hwang
Wei-Ting
WT
Pai
Ahna L H
AL
Boeving
Alexandra
A
Reilly
Anne
A
D000223:Adaptation, Psychological; D000293:Adolescent; D001007:Anxiety / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy*; D002648:Child; D003469:Culture; D003863:Depression / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy*; D005196:Family Therapy; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000175:diagnosis* / Q000523:psychology* / Q000628:therapy; D010290:Parents / Q000193:education / Q000523:psychology*; D018579:Patient Selection; D010555:Personality Inventory / Q000706:statistics & numerical data; D011594:Psychometrics; D011615:Psychotherapy, Group; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013313:Stress Disorders, Post-Traumatic / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy*