Research results in demand among trial participants and their parents

When surveyed, 54.3% of parents and 37.2% of adolescents found no good reasons to avoid providing results.

Most adolescents and parents of children with cancer involved in clinical trials have a strong desire to be informed of and understand research results, according to data from a multicenter survey. Given the choice, the majority of adolescents and parents prefer to receive the results prior to publication.

In light of data showing the importance of sharing trial results with participants or their parents, researchers conducted a multinational, multicenter study to determine the needs and attitudes of participants and the best way for medical experts to communicate results.

Researchers surveyed 627 parents and 185 adolescents who were diagnosed with cancer in a pediatric institution and aged at least 12 years or older at the time of the study. Participants were asked about their preferred method of receiving research results, including: implications, timing, provider and content of the results, their reasoning for and against providing results and any barriers to providing them.

The questionnaires included the Positive and Negative Affect Schedule for Children or Positive and Negative Affect Schedule – Expanded Form measure of affect to help predict the desired method for returning results.

The analysis included 409 parent questionnaires and 86 adolescent questionnaires; 19 parent respondents had a deceased child. Seventy-one percent of parents and 59% of adolescents expressed the desire to obtain a summary of the results of the current study.

Preferred methods of receipt

The right to be offered results was felt strongly by most parents; however the feeling was less strong if their child had reached an age of maturity. Similarly, adolescents felt both a strong (28%) and very strong (57%) right to results.

Participants were posed with a hypothetical situation as participants in a study. Results of the study were labeled as good (participant potentially benefited), bad (participant potentially harmed) and neutral (results the same for all participants regardless of treatment). Study participants indicated the method by which they would want to receive each category of results.

Both groups preferred to receive negative results in a personal manner of communication; however, 43% of adolescents preferred an e-mail or letter.

When questioned about who should deliver good, bad and neutral results, 22.2% of parents preferred the researcher. The cancer physician was preferred by 21.3%, the family physician by 8.1% and the research nurse by 16.1%. One hundred twenty-one parents (29.6%) did not feel the need for personal contact, according to the researchers.

The researcher was also the most preferred provider of results among adolescents (32.6%). The cancer physician was preferred by 25.6%, the family physician by 4.7% and the research nurse by 9.3%. Fourteen (16.3%) did not feel the need for personal contact.

Information requested and timing of return

Factual information, health implications for the child and general research information generated the themes for parent and adolescent information needs. Ninety-one percent of parents wanted a list of scientific publications generated from the study; only 59% of adolescents showed interest in such a list.

Parents and adolescents were given a brief description of the data analysis and peer-review processes involved in medical publication. Based on this, most parents wanted to be informed prior to publication: 33.3% preferred to know as soon as the study was accepted for publication, 26.9% after peer review but prior to publication, 24.0% at the study’s conclusion and analysis and 12.0% after publication.

Adolescents showed similar desires: 32.6% preferred to receive results at the study’s conclusion and analysis, 25.6% as soon as the study was accepted for publication, 15.1% after peer review but prior to publication and 12.8% after publication.

Reasoning and barriers

Most parents (77.0%) and adolescents (62.8%) indicated that research results should be offered to provide information that may improve quality of life. Raising public awareness of the importance of research was also important to both parents (68.9%) and adolescents (58.1%). Providing information that may prevent future harm, emphasizing the importance of the participant to the specific research project and research in general were also important reasons, to both parents and adolescents, to offer information.

Most parents (54.3%) and adolescents (37.2%), however, found no good reasons to avoid giving results. Distress for families if the participant had since died was chosen as a reason not to offer results among 29.1% of parents and 31.4% of adolescents. However, according to the researchers, this reason was not statistically different for parents of a deceased child vs. those of a living child.

In terms of barriers to the return of research results, 46.7% of parents indicated that a serious complication or death would make it more difficult to personally receive results; though this opinion did not differ significantly between parents of deceased children and those of living children.

Concern about the ability of the researcher to provide results in a comprehendible manner was of concern to 35.5% of parents and 50.0% of adolescents. Barriers such as thinking about the original illness were less concerning for parents (17.1%) and adolescents (9.3%), along with the costs related to getting results (16.6% of parents and 26.7% of adolescents). A lack of time concerned 23.3% of adolescents.

“The future offers opportunities to systematically explore the impact on participants, researchers and the research enterprise of different modalities for the offer and return of results to participants,” the researchers wrote. “The detailed preferences provided here allow for the researchers to plan for a responsive process in offering to provide research results.” – by Stacey L. Adams

J Clin Oncol. 2009;doi:10.1200/JCO.2008.18.5223.
J Clin Oncol. 2009;doi:10.1200/JCO.2008.20.0865.

The take-home message from this study is consistent with what has been shown over and over again: When you ask people who have been on studies or people who haven’t been on studies but have cancer, if they think they would want the results of a clinical trial that they participated in or could participate in, the vast majority say yes.

Ideally, we would routinely share results with patients, particularly in phase-3 studies where people are randomized and could have received another arm or another treatment. Given this is cancer, in many studies by the time results are available, people are not available to receive them. But in numerous studies they are. In particular, adjuvant studies; people remain at risk for the disease to come back and could have gotten a better treatment or suboptimal therapy, in retrospect.

– Ann H. Partridge, MD

Dana-Farber Cancer Institute and Harvard Medical School